5/20/23, 9:45 AM MD - Medical Devices

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1001 IMP/IVD/2020/000442 Kopran Laboratories FE Calibrator II(Dirui)-This product is used to CDSCO Class B
Limited calibrate Urine Sediment Analyzer, FUS Series
Urinalysis Hybrid and MUS Series Urinalysis
System to ensure test accuracy,Diluent(Dirui)-
Diluting sample,Urine Conductivity Analysis
Control(Dirui)-It is used for QC of Urinalysis
Hybrid and Urinalysis System testing
conductivity items,Urine Conductivity Analysis
Calibrator(Dirui)-It is used for Calibration of
Urinalysis Hybrid and Urinalysis System testing
conductivity item,Sheath(Dirui)-Used to wrap
the sample to from a sheath fl ow to count
formed elements in urine.,FUS-14Ca II(Dirui)-
FUS-14Ca II Urinalysis Strips is used for
qualitative or semi-quantitative test of
urobilinogen, bilirubin, ketone, blood, protein,
nitrite, leukocytes,glucose, specific gravity, pH,
ascorbic acid, microalbumin, creatinine and
Ca.,FUS-11MA II(Dirui)-FUS-11MA II Urinalysis
Strips is used for qualitative or semiquantitative
test of urobilinogen, bilirubin, ketone, blood,
protein, pH, nitrite, leukocyte, glucose, specific
gravity and microalbumin.,FUS-11 II(Dirui)-
FUS-11 II Urinalysis Strips is used for
qualitative or semi-quantitative test of
urobilinogen, bilirubin, ketone, blood, protein,
nitrite, leukocyte, glucose, specific gravity, pH
and ascorbic acid.,FUS-10 II(Dirui)-FUS-10 II
Urinalysis Strips is used for qualitative or semi-
quantitative test of urobilinogen, bilirubin,
ketone, blood, protein, nitrite, leukocytes,
glucose, specific gravity and pH,FE Focus B
II(Dirui)-This product is used to determine
position of focal plane of microscopic imaging
system for Urine Sediment Analyzer, FUS
Series Urinalysis Hybrid and MUS Series
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Urinalysis System to ensure test accuracy.,FE
Control II Positive Control(Dirui)-This product is
used for QC of test process of Urine Sediment
Analyzer, FUS series urinalysis hybrid and
MUS series urinalysis system.,FE Control II
Negative Control(Dirui)-This product is used for
QC of test process of Urine Sediment Analyzer,
FUS series urinalysis hybrid and MUS series
urinalysis system.,Cleaning liquid II(Dirui)-For
the cleaning and rising of the tubing
system.,FUS-13Cr II(Dirui)-FUS-13Cr II
Urinalysis Strips is used for qualitative or semi-
quantitative test of urobilinogen, bilirubin,
ketone, blood, protein, pH, nitrite, leukocyte,
glucose, specific gravity, ascorbic acid,
microalbumin and creatinine.,FUS-12MA
II(Dirui)-FUS-12MA II Urinalysis Strips is used
for qualitative or semiquantitative test of
urobilinogen, bilirubin, ketone, blood, protein,
pH, nitrite, leukocyte, glucose, specific gravity,
ascorbic acid and microalbumin.,CS-Acidic
Detergent(DIRUI)-"For cleaning reagent probe
and reaction cuvette of CS series Auto-
Chemistry Analyzer",H12-800MA(DIRUI)-For
the determination of kidney failure, diabetes or
related kidney damage,H11-800(DIRUI)-For the
determination of kidney failure, diabetes or
related kidney damage,CS-ISE
DETERGENT(DIRUI)-Cleaning of Analyser
System,BF Diluent(DIRUI)-For Diluting
sample,BF Detergent(DIRUI)-"It is used to
remove lyse, cell residue and protein in the
analyzer",ISE blood quality control(HIGH and
LOW)(DIRUI)-"This product is applicable to the
ion-selective electrode module of CS series
Auto chemistry analyzer for measuring

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
electrolyte",BF-FDT Lyse(DIRUI)-"For the
dissolution of red blood cell, dye of cell, content
detection of lymphocyte, monocyte, eosinophil
and neutrophil",Cleaning Liquid for
Refractometer and Turbidimeter(DIRUI)-
Cleaning of Analyser System,CS-Alkaline
Detergent(DIRUI)-"For cleaning reagent probe
and reaction cuvette of CS series Auto-
Chemistry Analyzer",Clinical Chemical Quality
Control Serum(DIRUI)-"Quality control serum is
used for the determination of accuracy or
repeatability of clinical chemical items.",Clinical
Chemical Calibration Serum(DIRUI)-
"Calibration serum is used for the determination
of accuracy or repeatability of clinical chemical
items.",BF-FDO Lyse(DIRUI)-"For the
dissolution of red blood cell, dye of cell, content
detection of lymphocyte, monocyte, eosinophil
and neutrophil",BF-6500 Lyse _SLS-I_(DIRUI)-
"For red blood cells dissolution and
haemoglobin releasing, content detection of
haemoglobin",H13-Cr(DIRUI)-For the
determination of kidney failure, diabetes or
related kidney damage,Urine Sediment
Analyzer Detergent(DIRUI)-"For cleaning pipe
lines and flow cell during analysis",Urinalysis
Control Positive(DIRUI)-"Urinalysis control is
used for quality control urinalysis strip and
analyzer",Urinalysis Control Negative(DIRUI)-
"Urinalysis control is used for quality control
urinalysis strip and analyzer",H14 Ca Urinalysis
Reagent Strips(DIRUI)-For the determination of
kidney failure, diabetes or related kidney
damage,H10-800 Urinalysis Reagent
Strips_wecompress(DIRUI)-For the
determination of kidney failure, diabetes or

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
related kidney damage,H Series Urine Analyzer
Control Liquid for Turbidity(DIRUI)-"For
monitoring accuracy of Turbidity during
Analysis",H series urine analyzer Control liquid
for Specific gravity(DIRUI)-"For Level 3 QC
determination of SG during analysis",H series
urine analyzer Color Control(DIRUI)-"For Color
Control determination during analysis",H series
urine analyzer Calibration liquid for
Turbidity(DIRUI)-For Calibration of Turbidity
during analysis,H Series Urine Analyzer
Calibration liquid for Specific gravity(DIRUI)-
"For Calibration of Specific Gravity during
analysis",H 10 Urinalysis Strips(DIRUI)-For the
determination of kidney failure, diabetes or
related kidney damage,Diluent(DIRUI)-For
Diluting sample,Control for Automatic
Hematology Analyzer _5-part_(DIRUI)-"It is
used for monitoring or evaluation test result
accuracy of 5-part Hematology
Analyzer",Cleaning liquid(DIRUI)-"For cleaning
pipe lines and flow cell during analysis",8 Items
Urinalysis Reagent Strips(DIRUI)-For the
determination of kidney failure, diabetes or
related kidney damage,5 Items Urinalysis
Reagent Strips(DIRUI)-flow to conduct urine
physical component counting,Sheath(DIRUI)-
Used to wrap the sample to form a sheath,ISE
Standard Solution(DIRUI)-"This product is
applicable to the ion-selective electrode module
of CS series Auto chemistry analyzer for
measuring electrolyte",ISE Reference
Solution(DIRUI)-"This product is used to
determine the electric potential of a reference
electrode",ISE Internal standard
Solution(DIRUI)-"The product applies to ISE

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
part of CS serial Auto Chemistry Analyzer",ISE
Diluent(DIRUI)-For the Diluting Sample,ISE
blood sample calibrator(DIRUI)-"This product is
applicable to the ion-selective electrode module
of CS series Auto chemistry analyzer for
measuring electrolyte",CS-Anti-Bacterial
Phosphor-Free Detergent(DIRUI)-"For Cleaning
reagent probe, incubation bath and reaction
cuvette of CS series Auto-Chemistry
Analyzer",Kit for Urine sediment
analyser(DIRUI)-For Sediment analysis in
Urine,ADA ADENOSINE DEAMINASE
ACTIVITY(DIRUI)-in vitro quantitative
measurement of adenosine deaminase activity
in human serum or plasma ,Mg- XB
MAGNESIUM(DIRUI)-In vitro quantitative
determination of magnesium concentration in
human serum or plasma,PHOS
PHOSPHORUS(DIRUI)-In vitro quantitative
determination of phosphorus concentration in
human serum or plasma,C3 COMPLEMENT
3(DIRUI)-In vitro quantitative measurement of
complement 3 reagent of human serum or
plasma,HCY HOMOCYSTEINE(DIRUI)-In vitro
quantitative measurement of homocysteine
content in human serum or plasma,CO2
CARBON DIOXIDE(DIRUI)-In vitro quantitative
measurement of carbon dioxide content in
human serum or
plasma,CHOLINESTERASE(DIRUI)-In vitro
quantitative determination of concentration of
Cholinesterase in human serum,P-AMY
PANCREATIC AMYLASE(DIRUI)-In vitro
quantitative determination of concentration of
Pancreatic Amylase In human serum,FE
FERRUS(DIRUI)-In vitro quantitative

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
determination of concentration of Ferrus In
human serum,TIBC TOTAL IRON BINDING
CAPACITY(DIRUI)-In vitro quantitative
determination of concentration of TIBC In
human serum,FER FERRITIN(DIRUI)-In vitro
quantitative determination of concentration of
Ferritin in human serum,Mb
MYOGLOBIN(DIRUI)-In vitro quantitative
determination of concentration of Myoglobin in
human serum,alpha 1 - Mg 1
MICROGLOBULIN(DIRUI)-In vitro quantitative
determination of concentration of β2-
Microglobulin in human serum,LPS
LIPASE(DIRUI)-In vitro quantitative
determination of concentration of Lipase in
human serum,T - BILL TOTAL
BILIRUBIN(DIRUI)-In vitro quantitative
determination of concentration of Total Bilirubin
in human serum,AST ASPARTATE
AMINOTRANSFERASE(DIRUI)-In vitro
quantitative determination of concentration of
ASPARTATE AMINOTRANSFERASE in human
serum,UA URIC ACID(DIRUI)-In vitro
quantitative determination of concentration of
Uric acid in human serum,Zn ZINC(DIRUI)-In
vitro quantitative determination of concentration
of Zinc in human serum,TC
CHOLESTEROL(DIRUI)-In vitro quantitative
determination of concentration ofTotal
Cholesterol in human serum,ALT ALANINE
AMINOTRANSFERASE(DIRUI)-In vitro
quantitative measurement of ALT activity in
human serum ,ALP ALKALINE
PHOSPHATASE(DIRUI)-In vitro quantitative
measurement of the activity of ALP in human
serum or plasma,GGT GAMMA GLUTAMYL

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
TRANSFERASE(DIRUI)-In vitro quantitative
measurement of the activity of GGT in human
serum and plasma.,TP TOTAL
PROTEIN(DIRUI)-In vitro quantitative
measurement of total protein content of human
serum or plasma,ALB ALBUMIN(DIRUI)-In vitro
quantitative measurement of albumin of
concentration serum or plasma,GLDH
GLUTAMATE DEHYDROGENASE(DIRUI)-In
vitro quantitative determination of glutamate
dehydrogenase activity of human serum,D-BILL
DIRECT BILIRUBIN(DIRUI)-In vitro quantitative
measurement of D-bilirubin concentration of
human serum or plasma,GLU-HK GLUCOSE
HEXO KINASE(DIRUI)-In vitro quantitative
measurement of the Glucose concentration
contained in human serum, plasma or
urine.,GLU-OX GLUCOSE(DIRUI)-In vitro
quantitative measurement of the Glucose
concentration contained in human serum,
plasma or urine.,FMN
FRUCTOSAMINE(DIRUI)-In vitro quantitative
measurement of fructosamine concentration in
human serum.,BUN BLOOD UREA
NITROGEN(DIRUI)-In vitro quantitative
measurement of UREA concentration of human
serum, plasma, or urine.,CRE- ENZYME
CREATININE(DIRUI)-In vitro quantitative
measurement of creatinine concentration of
human serum, plasma or urine,TG
TRIGLYCERIDE(DIRUI)-In vitro quantitative
measurement of triglycerides concentration of
human serum or plasma.,HDL-C HIGH
DENSITY LIPOPROTEIN(DIRUI)-In vitro
quantitative determination of High Density
Lipoprotein-Cholesterol (HDL-C) concentration

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
of human serum,LDL-C LOW DENSITY
LIPOPROTEIN(DIRUI)-In vitro quantitative
determination of Low Density Lipoprotein-
Cholesterol (LDL-C) concentration of human
serum,CK CREATININE KINASE(DIRUI)-In
vitro quantitative measurement of creatinine
kinase (CK) of human serum or plasma.,CK-
MB CREATINIE KINASE ISOENZYME(DIRUI)-
In vitro quantitative measurement of activity of
CK-MB isoenzyme in human serum .,LDH
LACTATE DEHYDROGENASE(DIRUI)-In vitro
quantitative determination of the activity of LDH
in human serum or plasma.,HBDH -Alpha
HYDROXYBUTYRATE
DEHYDROGENASE(DIRUI)-In vitro
quantitative measurement of the activity of α-
hydroxybutyrate dehydrogenase（α-HBDH）in
serum or plasma,AMY AMYLASE(DIRUI)-In
vitro quantitative determination of ɑ-amylase
activity of human serum or urine.,Ca-CPC
CALCIUM(DIRUI)-In vitro quantitative
determination of Calcium concentration of
serum, plasma or urine,Ca-ARS CALCIUM
ARSENAZO(DIRUI)-In vitro quantitative
determination of Calcium concentration of
serum, plasma or urine.,C4 COMPLEMENT
4(DIRUI)-In vitro quantitative measurement of
complement 4 reagent of human serum or
plasma,IgA IMMUNOGLOBULIN A(DIRUI)-In
vitro quantitative measurement concentration of
IgA of human serum,IgM IMMUNOGLOBULIN
M(DIRUI)-In vitro quantitative measurement
content of IgM of human serum.,IgG
IMMUNOGLOBULIN G(DIRUI)-In vitro
quantitative measurement content of IgG of
human serum.,ASO ANTI-STREPTOLYSIN

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
O(DIRUI)-In vitro quantitative measurement of
anti-streptolysin O in human serum or
plasma.,RF RHEUMATOID FACTOR(DIRUI)-In
vitro quantitative determination of rheumatoid
factor content in human serum.,PA
PREALBUMIN(DIRUI)-In vitro quantitative
measurement of prealbumin content of human
serum or plasma.,TRF TANSFERRIN(DIRUI)-In
vitro quantitative determination of concentration
of transferrin in human serum ,LP (a)
LIPOPROTEIN (a)(DIRUI)-In vitro quantitative
determination of lipoprotein (a) content in
human serum.,MALB MICROALBUMIN(DIRUI)-
quantitative measurement of microalbumin
content in human urine.,TBV TOTAL
BILIRUBIN(DIRUI)-In vitro quantitative
determination of concentration of Total Bilirubin
in human serum,DBV DIRECT
BILIRUBIN(DIRUI)-In vitro quantitative
determination of concentration of Direct
Bilirubin in human serum,APO B
APOLIPOPROTEIN B(DIRUI)-In vitro
quantitative measurement of apolipoprotein B
(Apo B) content in human serum,APO A1
APOLIPOPROTEIN A1(DIRUI)-In vitro
quantitative measurement of apolipoprotein A1
（Apo A1）content in human serum,HbA1c
glycohemoglobin A1C(DIRUI)-In vitro
quantitative measurement of glycohemoglobin
content in human blood.,CYC- C CYSTATIN
C(DIRUI)-In vitro quantitative measurement of
cystatin C content in human serum or plasma.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1002 IMP/IVD/2020/000443 Abbott Healthcare Pvt. Alinity m multi-Collect Specimen Collection Kit CDSCO Class A
Ltd. (Alinity m multi-Collect Specimen Collection
Kit)-The Alinity m multi-Collect Specimen
Collection Kit is intended for the collection and
transportation of male and female urine
specimens, endocervical swab specimens, and
vaginal swab specimens to stabilize nucleic
acid from these specimens. The collected
specimens are intended to be tested on the
automated Alinity m System. ,Alinity m
Specimen Dilution Kit I(Alinity m Specimen
Dilution Kit I)-The Alinity m Specimen Dilution
Kit I is intended to allow dilution of specimens
for testing on the automated Alinity m System
for measurement of nucleic acid,Alinity m Cervi-
Collect Specimen Collection Kit(Alinity m Cervi-
Collect Specimen Collection Kit)-Alinity m
Cervi-Collect Specimen Collection Kit is
intended for the collection and transportation of
cervical specimens for the detection of human
papillomavirus (HPV). The collected specimens
are intended to be tested on the automated
Alinity m System.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1003 IMP/IVD/2020/000443 Abbott Healthcare Pvt. Abbott Multi collect specimen collection CDSCO Class B
Ltd. kit(Abbott Multi collect specimen collection kit)-
The Abbott multi-Collect Specimen Collection
Kit is intended for the collection and
transportation of urine specimens, and of
endocervical, male urethral, and vaginal swab
specimens for the detection of Chlamydia
trachomatis and Neisseria gonorrhoeae.,Abbott
Cervi-collect specimen collection kit(Abbott
Cervi-collect specimen collection kit)-The
Abbott Cervi-Collect Specimen Collection Kit is
intended for the collection and transportation of
cervical specimens for the detection of Human
papillomavirus (HPV) per the instructions
provided.,Abbott Multi collect specimen
collection kit (P/Cap)(Abbott Multi collect
specimen collection kit (P/Cap))-The Abbott
multi-Collect Specimen Collection Kit (List No.
9K12-02) is intended for the collection and
transportation of urine specimens, and of
endocervical, male urethral, and vaginal swab
specimens for the detection of Chlamydia
trachomatis and Neisseria gonorrhoeae.

1004 IMP/IVD/2020/000444 DiaSys Diagnostic SARS-CoV-2 Antibody Test (Colloidal Gold CDSCO Class C
India Private Limited Immunochromatography)(Lepu)-The product is
intended for the qualitative detection of
antibody content against SARS-CoV-2 in
clinical samples (serum/plasma/whole blood).

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1005 IMP/IVD/2020/000449 WOCKHARDT LTD Blood Glucose Test Strips(Sugarchek Advance CDSCO Class B
(U Right TD-4279))-Used for quantitative
measurement of glucose in human whole
blood.,Blood Glucose Test Strips(SUGARCHEK
(Achtung TD-4207))-Used for quantitative
measurement of glucose in human whole
blood.

1006 IMP/IVD/2020/000449 WOCKHARDT LTD Blood Glucose Monitoring CDSCO Class C

System(SUGARCHEK (Achtung TD-4207))-To
determine the concentration of Glucose in
blood,Blood Glucose Monitoring
System(SUGARCHEK ADVANCE (URIGHT
TD-4279))-To determine the concentration of
Glucose in blood

1007 IMP/IVD/2020/000450 Indian Orthocare Viral Transport Medium (VTM) Kit(Mole CDSCO Class A
Surgicals Bioscience)-This kit is used for sample
collection, transmission and preservation.

1008 IMP/IVD/2020/000451 JETTALABS LLP CORONA VIRUS IgG/IgM TEST CASSETTE CDSCO Class C
(OZO)-This Product is used for in Vitro
Qualitative Detection of Corona Virus
(SARSCoV-2) IgM/IgG Antibody in the human
serum, plasma and whole blood samples.

1009 IMP/IVD/2020/000452 Prosper Channel Novel Corona Virus (2019-nCoV)RT-PCR CDSCO Class C
Lifescience India Pvt. Detection Kit(Fosun 2019-nCoV qPCR)-This
Ltd product is intended for the rapid detection of
2019-nCOV in human throat swab or sputum
samples.Coronavirus is a +ssRNA virus with
envelope. Its diameter is about 80-120 nm.This
kit is intended for the detection of 2019-nCOV
and is helpful for clinical diagnosis of 2019-
nCOV infection.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1010 IMP/IVD/2020/000453 Kin Diagnostics IgG kit(Nephstar)-quantitative determination of CDSCO Class B

human IgG ,ALB kit(Nephstar)-quantitative
determination of human ALB ,AMG
kit(Nephstar)-quantitative determination of
human AMG ,AAT kit(Nephstar)-quantitative
determination of human AAT ,C1IN
kit(Nephstar)-quantitative determination of
human C1IN,PAB kit(Nephstar)-quantitative
determination of human PAB ,C4 kit(Nephstar)-
quantitative determination of human C4,Cys C
kit(Nephstar)-quantitative determination of
human Cys C ,BMG kit-quantitative
determination of human BMG,mALB
kit(Nephstar)-quantitative determination of
human mALB,LAM kit(Nephstar)-quantitative
determination of human LAM,KAP
kit(Nephstar)-quantitative determination of
human KAP,AT3 kit(Nephstar)-quantitative
determination of human AT3 ,Apo B
kit(Nephstar)-quantitative determination of
human Apo B ,Apo A1 kit(Nephstar)-
quantitative determination of human Apo
A1,CER kit(Nephstar)-quantitative
determination of human CER ,HPT
kit(Nephstar)-quantitative determination of
human HPT ,CRP kit(Nephstar)-quantitative
determination of human CRP ,IgA
kit(Nephstar)-quantitative determination of
human IgA,IgM kit(Nephstar)-quantitative
determination of human IgM ,AAG
kit(Nephstar)-quantitative determination of
human AAG ,C3 kit(Nephstar)-quantitative
determination of human C3,RF kit(Nephstar)-
quantitative determination of human RF,TRF
kit(Nephstar)-quantitative determination of
human TRF ,ASO kit(Nephstar)-quantitative
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
determination of human ASO ,RBP
kit(Nephstar)-quantitative determination of
human RBP ,Lipoprotein(a) kit(Nephstar)-
quantitative determination of human
Lipoprotein(a) ,SAA kit(Nephstar)-quantitative
determination of human SAA ,D-Dimer
kit(Nephstar)-quantitative determination of
human D-Diamr ,UsCRP kit(Nephstar)-
quantitative determination of human UsCRP ,α1
Microglobulin kit(Nephstar)-quantitative
determination of human α1 Microglobulin
,HbA1c kit(Nephstar)-quantitative determination
of human HbA1c ,bCRP kit(Nephstar)-
quantitative determination of human bCRP

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1011 IMP/IVD/2020/000454 Thermo Fisher LABScreen™ MICA Single Antigen - Group CDSCO Class C
Scientific India Pvt. Ltd. 1(LABScreen)-LABScreen products are
intended for use in detection of HLA antibody
using flow cytometric technology,LABScreen
Negative Control(LABScreen )-This reagent is
for use as an indicator of the non-specific
background signal of each LABScreen™ and
LABScreen™ Multi* bead (HLA-coated beads,
as well as negative and positive control beads)
when reacting with a serum sample that does
not contain any anti-HLA Class I or Class II
antibody. This reagent may only be used with
LABScreen™ products.,PE Conjugated Goat
Anti-Human IgG(LabScreen)-For use in the
detection of human IgG in the LABScreen™
and LABScreen™ Multi assays.,LABType™
SSO MICA(LABType)-DNA typing of HLA Class
I or Class II alleles,PE-Conjugated
Streptavidin(LabType)-For use in detection of
biotinylated proteins and nucleic acids in LAB
Type SSO TYPING TESTS and LAB Type XR
and CWD DNA Typing Test assay,LABScreen™
PRA Class I(LABScreen)-LABScreen products
are intended for use in detection of HLA
antibody using flow cytometric
technology,FlowPRA™ HLA Class I Screening
Test(FlowPRA)-The FlowPRA™ Screening Test
is intended for use in flow cytometric detection
of HLA- specific antibodies in serum of pre and
post-transplant organ recipients.,LABScreen™
Single Antigen HLA Class II - Group
1(LABScreen)-LABScreen products are
intended for use in detection of HLA antibody
using flow cytometric technology,LABScreen™
Mixed Class I & II(LABScreen)-LABScreen
products are intended for use in detection of
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
HLA antibody using flow cytometric
technology,FlowPRA™ Wash Buffer (10X)
(FlowPRA)-The FlowPRA™ Wash Buffer is
intended for use with FlowPRA™ Screening
Tests when a larger volume of wash buffer than
that normally supplied with the test is
required.,FlowPRA™ Class II Positive
Control(FlowPRA)-The FlowPRA™ Screening
Test is intended for use in flow cytometric
detection of HLA- specific antibodies in serum
of pre and post-transplant organ
recipients.,FlowPRA™ HLA Class II Screening
Test(FlowPRA)-The FlowPRA™ Screening Test
is intended for use in flow cytometric detection
of HLA-specific antibodies in serum of pre and
post-transplant organ recipients.,FlowPRA™
Class l Positive Control(FlowPRA)-The
FlowPRA™ Screening Test is intended for use
in flow cytometric detection of HLA- specific
antibodies in serum of pre and post-transplant
organ recipients.,LABType™ SSO Class I Bw4
Supplement Typing Test(LABType)-DNA typing
of HLA Class I or Class II alleles, LABType™
SSO Class II DQA1/DQB1 Typing Test(
LABType)-DNA typing of HLA Class I or Class II
alleles,LABType™ SSO Class II DRB1 Typing
Test(LABType)-DNA typing of HLA Class I or
Class II alleles,LABType™ SSO Class II
DPA1/DPB1 Typing Test(LABType)-DNA typing
of HLA Class I or Class II alleles,FlowPRA™
HLA Class I & II Screening Test(FlowPRA)-The
FlowPRA™ Screening Test is intended for use
in flow cytometric detection of HLA- specific
antibodies in serum of pre and post-transplant
organ recipients.,LABScreen™ Single Antigen
HLA Class II Supplement - Group

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
1(LABScreen)-LABScreen products are
intended for use in detection of HLA antibody
using flow cytometric technology,LABScreen™
PRA Class II(LABScreen)-LABScreen products
are intended for use in detection of HLA
antibody using flow cytometric
technology,LABScreen™ Single Antigen HLA
Class I Supplement - Group 1(LABScreen)-
LABScreen products are intended for use in
detection of HLA antibody using flow cytometric
technology,LABType™ SSO Class I A Locus
Typing Test(LABType)-DNA typing of HLA Class
I or Class II alleles,LABType™ CWD Class II
DRB1 Typing Test(LABType)-For use to
determine HLA A, B, C and DRB1 locus typing
to aid in transfusion and transplantation donor
recipient matching., LABType™ SSO Class I B
Locus Typing Test( LABType)-DNA typing of
HLA Class I or Class II alleles,LABScreen™
Single Antigen HLA Class I -
Combi(LABScreen)-LABScreen products are
intended for use in detection of HLA antibody
using flow cytometric technology,LABType™
SSO Class I C Locus Typing Test(LABType)-
DNA typing of HLA Class I or Class II
alleles,LABType™ SSO Class I Exon 4-7
Supplement Typing Test - 20 tests(LABType)-
DNA typing of HLA Class I or Class II
alleles,LABType™ SSO Class I B7 Supplement
Typing Test Tests(LABType)-DNA typing of HLA
Class I or Class II alleles,LABType™ CWD
Class I C Locus Typing Test(LABType)-For use
to determine HLA A, B, C and DRB1 locus
typing to aid in transfusion and transplantation
donor recipient matching.,LABType™ CWD
Class I B Locus Typing Test(LABType)-For use

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
to determine HLA A, B, C and DRB1 locus
typing to aid in transfusion and transplantation
donor recipient matching.,LABType™ CWD
Class I A Locus Typing Test(LABType)-For use
to determine HLA A, B, C and DRB1 locus
typing to aid in transfusion and transplantation
donor recipient matching.,LABType™ XR Class
II DRB1 Typing Test(LABType)-For use to
determine HLA A, B, C and DRB1 locus typing
to aid in transfusion and transplantation donor
recipient matching.,LABType™ XR Class I C
Locus Typing Test(LABType)-For use to
determine HLA A, B, C and DRB1 locus typing
to aid in transfusion and transplantation donor
recipient matching.,LABType™ XR Class I B
Locus Typing Test(LABType)-For use to
determine HLA A, B, C and DRB1 locus typing
to aid in transfusion and transplantation donor
recipient matching.,LABType™ XR Class I A
Locus Typing Test(LABType)-For use to
determine HLA A, B, C and DRB1 locus typing
to aid in transfusion and transplantation donor
recipient matching.,Lyophilized Class II
Complement (NIL)- For use in complement
dependent cytotoxic assays for determining
HLA Class II cell surface antigens.,Lyophilized
Class I Complement (NIL)- For use in
Complement dependent cytotoxic assays for
determining HLA Class I cell surface
antigens.,Class II Complement(NIL)- For use in
complement dependent cytotoxic assays for
determining HLA Class II cell surface
antigens.,Class I Complement (NIL)- For use in
Complement dependent cytotoxic assays for
determining HLA Class I cell surface
antigens.,Terasaki HLA Class II Tissue Typing

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Tray(Terasaki )-For use in determining HLA cell
surface antigens with a complement dependent
microlymphocytotoxic test,LABType™ SSO
Class II DRB3,4,5 Typing Test(LABType)-DNA
typing of HLA Class I or Class II alleles,Terasaki
HLA-ABC Third Tissue Typing Tray(Terasaki )-
For use in determining HLA cell surface
antigens with a complement dependent
microlymphocytotoxic test,Terasaki HLA-ABC
Second Tissue Typing Tray(Terasaki)-For use in
determining HLA cell surface antigens with a
complement dependent microlymphocytotoxic
test,Terasaki HLA-ABC First Tissue Typing
Tray(Terasaki)-For use in determining HLA cell
surface antigens with a complement dependent
microlymphocytotoxic test,Micro SSP™ Allele
Specific HLA Class I DNA Typing Tray -
B*57(Micro SSP)-DNA typing of Class I or
Class II HLA alleles.,Micro SSP™ AmbiStrips™
Negative Control(Micro SSP)-DNA typing of
Class I or Class II HLA alleles.,Micro SSP™
AmbiStrips™ HLA Class II -DRB50110N(Micro
SSP)-DNA typing of Class I or Class II HLA
alleles.,Micro SSP™ AmbiStrips™ HLA Class II
-DRB50108N(Micro SSP)-DNA typing of Class I
or Class II HLA alleles.,Micro SSP™
AmbiStrips™ HLA Class II -DRB40103N(Micro
SSP)-DNA typing of Class I or Class II HLA
alleles.,Micro SSP™ AmbiStrips™ HLA Class I
- B27+ B81(Micro SSP)-DNA typing of Class I
or Class II HLA alleles.,Micro SSP™
AmbiStrips™ HLA Class I - B27+ B73(Micro
SSP)-DNA typing of Class I or Class II HLA
alleles.,Micro SSP™ High Resolution HLA
Class II DNA Typing Tray - DQA1(Micro SSP)-
DNA typing of Class I or Class II HLA

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
alleles.,Micro SSP™ High Resolution HLA
Class II DNA Typing Tray - DPA1/DPB1(Micro
SSP)-DNA typing of Class I or Class II HLA
alleles.,Micro SSP™ High Resolution HLA
Class II DNA Typing Tray(Micro SSP)-DNA
typing of Class I or Class II HLA alleles.,Micro
SSP™ Generic HLA Class I and II ABDR DNA
Typing Tray(Micro SSP)-DNA typing of Class I
or Class II HLA alleles.,Micro SSP™ Generic
HLA Class I and II DNA Typing Tray -
ABDRDQ(Micro SSP)-DNA typing of Class I or
Class II HLA alleles.,Micro SSP™ Generic HLA
Class II DNA Typing Tray(Micro SSP)-DNA
typing of Class I or Class II HLA alleles.,Micro
SSP™ Generic HLA Class II DNA Typing Tray -
DQB1 Only(Micro SSP)-DNA typing of Class I
or Class II HLA alleles.,Micro SSP™ Generic
HLA Class II DNA Typing Tray - DRB
Only(Micro SSP)-DNA typing of Class I or Class
II HLA alleles.,Micro SSP™ Generic HLA Class
II DRB/DQB1/DPB1 DNA Typing Tray(Micro
SSP)-DNA typing of Class I or Class II HLA
alleles.,Micro SSP™ HLA Class I C Locus
Specific DNA Typing Tray(Micro SSP)-DNA
typing of Class I or Class II HLA alleles.,Micro
SSP™ HLA Class I B Locus Specific DNA
Typing Tray(Micro SSP)-DNA typing of Class I
or Class II HLA alleles.,Micro SSP™ HLA Class
I A Locus Specific DNA Typing Tray(Micro
SSP)-DNA typing of Class I or Class II HLA
alleles.,Micro SSP™ HLA Class I DNA Typing
Tray - AB(Micro SSP)-DNA typing of Class I or
Class II HLA alleles.,Micro SSP™ Generic HLA
Class I DNA Typing Tray(Micro SSP)-DNA
typing of Class I or Class II HLA
alleles.,FlowPRA™ Specific HLA Class II

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Antibody Detection Test(FlowPRA)-The
FlowPRA® Specific Tests are intended for use
in flow cytometric detection of HLA antibodies
and their specificities.,FlowPRA™ Specific HLA
Class I Antibody Detection Test(FlowPRA)-The
FlowPRA® Specific Tests are intended for use
in flow cytometric detection of HLA antibodies
and their specificities.,FlowPRA™ Single
Antigen HLA Class II Antibody Detection
Test(FlowPRA)-The FlowPRA® Specific Tests
are intended for use in flow cytometric detection
of HLA antibodies and their
specificities.,FlowPRA™ Single Antigen HLA
Class I Antibody Detection Test(FlowPRA)-The
FlowPRA® Specific Tests are intended for use
in flow cytometric detection of HLA antibodies
and their specificities.,FlowPRA™ Reagent
Pack(FlowPRA)-The FlowPRA™ Reagent Pack
contains ancillary reagents used with the
FlowPRA™ Specific and FlowPRA™ Screening
Tests for detection of HLA antibodies and their
specificities.,FlowPRA™ Class l & II Negative
Control(FlowPRA)-The FlowPRA® Screening
Test is intended for use in flow cytometric
detection of HLA-specific antibodies in serum of
pre and post-transplant organ
recipients.,FlowPRA™ Control
Beads(FlowPRA)-FlowPRA™ Control Beads
are intended for use as blank control beads in
the FlowPRA™ Class I and/or II Screening
Tests to indicate the background level of the
testing serum.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1012 IMP/IVD/2020/000455 RAPID DIAGNOSTIC TriniCLOT Lupus Confirm-TriniCLOT Lupus CDSCO Class C
PVT. LTD. Screen and TriniCLOT Lupus Confirm are
simplified dilute Russell Viper Venom Time
(dRVVT) reagents, intended to specifically
detect Lupus Anticoagulants (LAs), a type of
antiphospholipid antibody. The reagents are
simple one-step-clotting tests that can be
performed either manually or on automated
coagulation instruments,TriniLIZE PAI-1
Activity-TriniLIZE PAI-1 Activity is a bio-
immunoassay (BIA) for the quantitative
determination of active human plasminogen
activator inhibitor, type 1 (PAI-1) in human
plasma,TriniCLOT Lupus Screen-TriniCLOT
Lupus Screen and TriniCLOT Lupus Confirm
are simplified dilute Russell Viper Venom Time
(dRVVT) reagents, intended to specifically
detect Lupus Anticoagulants (LAs), a type of
antiphospholipid antibody. The reagents are
simple one-step-clotting tests that can be
performed either manually or on automated
coagulation instruments,TriniLIZE PAI-1
Antigen-TriniLIZE PAI-1 Antigen is an enzyme
immunoassay (ELISA) for the quantitative
determination of human plasminogen activator
inhibitor, type 1 (PAI-1) antigen in human
plasma

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1013 IMP/IVD/2020/000456 Abbott Healthcare Pvt. Alinity h-series HemCal(Alinity h-series CDSCO Class B
Ltd. HemCal)-Alinity h-series HemCal is a whole
blood calibrator used to calibrate Alinity h-series
systems. Calibration values are provided for
WBC, RBC, HGB, MCV, PLT, and MPV
parameters.,Alinity h-series Control 29-P(Alinity
h-series Control 29-P)-Alinity h-series Control
29P is a Whole Blood hematology quality
control material used to monitor results
obtained on Alinity h-series systems.

1014 IMP/IVD/2020/000457 Twins Digital Services Blood Glucose Test Strip(PROCHECK CDSCO Class B
India Private Limited Advance)-Procheck Advance Blood Glucose
Test Strips, when use together with Procheck
Advance Multi-Functional Monitoring System,
allow your blood glucose levels to be measured
by yourself at home or by healthcare
professionals. It uses fresh capillary whole
blood samples from the finger, and from venous
whole blood. This system is not intended for
use in the diagnosis or screening of diabetes
mellitus. It can be used on neonates.
Professionals may use test strips to test
capillary and venous blood sample; home use
is limited to capillary whole blood
testing.,Ketone Test Strips(PROCHECK
Advance)-Procheck Advance Beta-Ketone Test
Strip is intended for the quantitative
measurement of Beta-Ketone in venous whole
blood and fresh capillary whole blood from
finger.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1015 IMP/IVD/2020/000457 Twins Digital Services Multi-Functional Monitoring System CDSCO Class C
India Private Limited (Glucometer)(PROCHECK Advance)-This
system is intended for use outside the body (in
vitro diagnostic use) to quantitatively measure
the blood glucose, β-ketone or total cholesterol
levels in whole blood. It is for home use or for
healthcare professional use. It should not be
used for diagnosis or screening of diseases.

1016 IMP/IVD/2020/000458 Biotron Healthcare Real-time fluorescent isothermal assay Kit for CDSCO Class C
(India) Pvt. Ltd Covid 19 detection(iAMP COVID-19 Detection
Kit)-iAMP COVID-19 Detection kit is a
multiplexed, real-time fluorescent RT-isothermal
assay based on Atila’s proprietary isothermal
amplification technology intended for the
qualitative detection of nucleic acid from the
SARS-CoV-2 in nasopharyngeal swabs,
oropharyngeal swabs or BAL from individuals
with signs and symptoms of infection who are
suspected of COVID-19.

1017 IMP/IVD/2020/000459 JETTALABS LLP Novel Coronavirus(2019-nCoV) Nucleic Acid CDSCO Class C
Diagnostic Kit-Novel Coronavirus(2019-nCoV)
Nucleic Acid Diagnostic Kit (PCR-Fluorescence
Probing) is used for qualitative detection of the
ORF1ab and N genes of novel coronavirus
(2019-nCoV) in nasopharyngeal swab,
oropharyngeal swab, alveolar lavage fluid,
sputum, serum, whole blood and feces from
suspected pneumonia cases with novel
coronavirus infection, patients with suspected
clusters of novel coronavirus infection, and
other patients requiring diagnosis or differential
diagnosis of novel coronavirus infection.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1018 IMP/IVD/2020/000460 M/s.Transasia Bio- COVID-19 IgG ELISA(ERBALisa COVID-19 CDSCO Class C
Medicals Ltd. IgG)-The ERBAlisa COVID-19 IgG Kit is
intended for the detection of IgG antibodies to
SARS-CoV-2 (COVID-19) in human serum or
plasma.

1019 IMP/IVD/2020/000462 Allied Biotechnology Smart Detect SARS-CoV- 2 rRT-PCR Kit-Smart CDSCO Class C
India Pvt. Ltd. Detect SARS-CoV-2 rRT-PCR Kit is a real-time
RT-PCR test intended for the qualitative
detection of nucleic acid from severe acute
respiratory syndrome-related coronavirus 2
(SARS-CoV-2) in human nasopharyngeal swab,
anterior nasal swab and mid-turbinate nasal
swab specimens from individuals suspected of
COVID-19 by their healthcare provider.

1020 IMP/IVD/2020/000465 365 Medical COVID 19 Real time PCR Kit(SARS-CoV- CDSCO Class C
2/SARS-CoV Multiplex REAL-TIME PCR
Detection Kit)-The SARS-CoV-2/SARS-CoV
Multiplex REAL-TIME PCR Detection Kit is
designed to detect COVID-19 virus in human
biological samples(nasopharyngeal swabs,
oropharyngeal swabs, bronchoalveolar lavage,
endotracheal aspirate, nasopharyngeal
aspirate, sputum). The kit is intended for use by
laboratory trained personnel.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1021 IMP/IVD/2020/000468 Siemens Healthcare FTD™ SARS-CoV-2(FTD™ SARS-CoV-2)-FTD CDSCO Class C

Private Limited SARS-CoV-2 is a semi-automated qualitative in
vitro nucleic acid amplification test for the
detection of ORF1ab and N gene of severe
acute respiratory syndrome coronavirus 2
(SARS-CoV-2) nucleic acids in nasopharyngeal
and oropharyngeal swabs of patients with signs
and symptoms of SARS-CoV-2 infection in
conjunction with clinical and epidemiological
risk factors, who are suspected of Coronavirus
Disease 2019 (COVID-19). The kit is intended
for professional use by laboratory personnel
trained in real-time PCR at a level 2 biosafety
laboratory or equivalent per local regulations.
The test is intended as an aid in the diagnosis
of infections caused by the new human
coronavirus SARS-CoV-2. For in vitro
diagnostic use.,FTD™ Respiratory pathogens
21(FTD™ Respiratory pathogens 21)-FTD
Respiratory pathogens 21 is a qualitative in
vitro nucleic acid amplification test for the
detection and differentiation of specific viral and
bacterial nucleic acids in nasopharyngeal swab
specimens of human origin. The test is
intended as an aid in the diagnosis of
respiratory infections caused by influenza A
virus (IAV), influenza A virus H1N1 swine-
lineage (IAV [H1N1] swl), influenza B virus
(IBV), human rhinovirus (HRV), human
coronaviruses (HCoV) 229E, NL63, HKU1, and
OC43, human parainfluenza viruses (HPIV) 1
through 4, human metapneumoviruses (HMPV)
A and B, human bocavirus (HBoV),
Mycoplasma pneumoniae (M. pneumoniae),
human respiratory syncytial viruses (HRSV) A
and B, human parechovirus (HPeV),
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
enterovirus (EV), and human adenovirus
(HAdV). For in vitro diagnostic use.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1022 IMP/IVD/2020/000469 ASPEN M-6LN LYSE(Mindray)-For the measurement of CDSCO Class B

DIAGNOSTICS PVT. NRBC-related parameters together with M-6FN
LTD. DYE,M-6LD LYSE(Mindray)-For use in WBC
differentiation in the DIFF channel together with
M-6FD LYSE.,M-6LH LYSE(Mindray)-For the
measurement of the haemoglobin-related
parameters.,M-6FN DYE(Mindray)-For the
measurement of NRBC-related parameters
together with M-6LN LYSE.,DS
DILUENT(Mindray)-For the measurement of
parameters related to RBC, PLT, WBC, RET
and NRBC,M-6FD DYE(Mindray)-For use in
WBC differentiation in the DIFF channel
together with M-6LD LYSE.As per product
insert,M-6DR DILUENT(Mindray)-For the
measurement of RET-related parameters
together with M-6FR DILUENT.,M-6FR
DYE(Mindray)-For the measurement of RET-
related parameters together with M-6DR
DILUENT.,DHEA-S Calibrators(Mindray)-
Mindray DHEA-S Calibrators (DHEA-S CAL)
are intended to calibrate the quantitative
Dehydroepiandrosterone sulfate (DHEA-S)
assay on Mindray CL-series
Chemiluminescence Immunoassay
Analyzer.,Total Human Chorionic Gonadotropin
(CLIA)(Mindray)-The CL-series Total HCG
assay is a Chemiluminescent Immunoassay
(CLIA) for the quantitative determination of total
human chorionic gonadotropin (Total HCG) in
human serum.,Eluent A(Mindray)-This product
applies to Mindray H50/H50P Automated
Glycohemoglobin Analyzer. The
productparticipates in the measurement of
HbA1c in blood samples,Hemolysis
Solution(Mindray)-This product applies to
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Mindray H50/H50P Automated
Glycohemoglobin Analyzer. Used forpre-
treatment of blood samples before HbA1c
analysis.,Eluent B(Mindray)-This product
applies to Mindray H50/H50P Automated
Glycohemoglobin Analyzer. The
productparticipates in the measurement of
HbA1c in blood samples,Free T3
Calibrators(Mindray)-Mindray Free T3
Calibrators (FT3 CAL) are intended to calibrate
the quantitative free triiodothyronine (FT3)
assay on Mindray CL-
seriesChemiluminescence Immunoassay
Analyzer.,Free Triiodothyronine (CLIA)
(Mindray)-The CL-series FT3 assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of free
triiodothyronine (FT3) in human serum.,Free T4
Calibrators(Mindray)-Mindray Free T4
Calibrators (FT4 CAL) are intended to calibrate
the quantitative free thyroxine (FT4) assay on
Mindray CL-series Chemiluminescence
Immunoassay Analyzer.,Free Thyroxine (CLIA)
(Mindray)-The CL-series FT4 assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of free thyroxine
(FT4) in human serum or plasma.,Insulin
Calibrators(Mindray)-Mindray Insulin
Calibrators (Insulin CAL) are intended to
calibrate the quantitative Insulin assay on
Mindray CL-series Chemiluminescence
Immunoassay Analyzer.,Insulin (CLIA)
(Mindray)-The CL-series Insulin assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination ofInsulin in human
serum or plasma.,LH Calibrators(Mindray)-

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No.  License Number  Name  Use  Authority  Class 
Mindray LH Calibrators (LH CAL) are intended
to calibrate the quantitative luteinizing hormone
(LH) assay on Mindray CL-series
Chemilumines-cence Immunoassay
Analyzer.,Luteinizing Hormone (CLIA)
(Mindray)-The CL-series LH assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of luteinizing
hormone (LH) in human serum or plasma.,MYO
Calibrators(Mindray)-Mindray Myoglobin
Calibrators (MYO CAL) are intended to
calibrate the quantitative Myoglobin (MYO)
assay on Mindray CL-series
Chemiluminescence Immunoassay
Analyzer,Myoglobin (CLIA)-The CL-series
Myoglobin assay is a Chemiluminescent
Immunoassay (CLIA) for the quantitative
determination ofmyoglobin (MYO) in human
serum or plasma.,Progesterone (CLIA)
(Mindray)-The CL-series PROG assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of progesterone
(PROG) in human serum.,Progesterone
Calibrators(Mindray)-Mindray Progesterone
Calibrators (PROG CAL) are intended to
calibrate the quantitative progesterone (PROG)
assay on Mindray CL-series
Chemiluminescence Immunoassay Analyzer.
,Testosterone (CLIA)(Mindray)-The CL-series
TESTO assay is a Chemiluminescent
Immunoassay (CLIA) for the quantitative
determination of testosterone (TESTO) in
human serum and plasma. ,Testosterone
Calibrators(Mindray)-Mindray Testosterone
Calibrators (TESTO CAL) are intended to
calibrate the quantitative testosterone (TESTO)

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
assay on Mindray CL-series Chemilumines-
cence Immunoassay Analyzer. ,Prolactin
Calibrators(Mindray)-Mindray Prolactin
Calibrators (PRL CAL) are intended to calibrate
the quantitative prolactin (PRL) assayon
Mindray CL-series Chemilumines-cence
Immunoassay Analyzer.,Thyroglobulin
Calibrators(Mindray)-Mindray Thyroglobulin
Calibrators (Tg CAL) are intended to calibrate
the quantitative thyroglobulin (Tg) assay on
Mindray CL-seriesChemiluminescence
Immunoassay Analyzer.,Thyroglobulin (CLIA)
(Mindray)-The CL-series Tg assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of thyroglobulin (Tg)
in human serum or plasma.,Total HCG
Calibrators(Mindray)-Mindray Total HCG
Calibrators (HCG CAL) are intended to
calibrate the quantitative total human chorionic
gonadotrophin (Total HCG) assay on Mindray
CL-series Chemiluminescence Immunoassay
Analyzer.,TSH Calibrators(Mindray)-Mindray
TSH Calibrators (TSH CAL) are intended to
calibrate the quantitative thyroid-stimulating
hormone (TSH) assay on Mindray CL-series
Chemiluminescence Immunoassay
Analyzer.,Thyroid-Stimulating Hormone (CLIA)
(Mindray)-The CL-series TSH assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of thyroid-stimulating
hormone (TSH) in human serum.,Substrate
Solution(Mindray)-Mindray Substrate Solution is
intended for use with the Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and specific Mindray immunoassay
reagents.,Parathyroid hormone (CLIA)

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No.  License Number  Name  Use  Authority  Class 
(Mindray)-The CL-series PTH assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of PTH in human
serum or plasma.,Folate Calibrators(Mindray)-
Mindray Folate Calibrators (Folate CAL) are
intended to calibrate the quantitative Folate
assay on Mindray CL-series
Chemiluminescence Immunoassay
Analyzer,System Wash Solution(Mindray)-
System Wash Solution is used to prime the
substrate dispensing tube in order to clean the
tubes.,25-OH-Vitamin D Total (CLIA)(Mindray)-
The CL-series VD-T assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of 25-OH-Vitamin D
Total in human serum or plasma. ,25-OH-
Vitamin D Total Calibrators(Mindray)-Mindray
25-OH-Vitamin D Total Calibrators (VD-T CAL)
are intended to calibrate the quantitative 25-
OH-Vitamin D Total assay on Mindray CL-
series Chemiluminescence Immunoassay
Analyzer.,PTH Calibrators(Mindray)-Mindray
PTH Calibrators (PTH CAL) are intended to
calibrate the quantitative PTH assay on
Mindray CL-series Chemiluminescence
Immunoassay Analyzer.,Vitamin B12
Calibrators(Mindray)-Mindray Vitamin B12
Calibrators (VB12 CAL) are intended to
calibrate the quantitative VB12 assay on
Mindray CL-series Chemiluminescence
Immunoassay Analyzer.,Vitamin B12 (CLIA)
(Mindray)-The CL-series Vitamin B12 (VB12)
assay is a Chemiluminescent Immunoassay
(CLIA) for the quantitative determination of
Vitamin B12 in human serum or plasma.,Folate
(CLIA)(Mindray)-The CL-series Folate assay is

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
a Chemiluminescent Immunoassay (CLIA) for
the quantitative determination of folate in
human serum, plasma or red blood cells.,Red
Blood Cell Folate Releasing Reagent(Mindray)-
Red Blood Cell Folate Releasing Reagent is
used for the pretreatment of whole blood
samples to release folates in erythrocytes (red
blood cells, RBC), in order to testing the folate
concentration in erythrocytes using the Folate
(CLIA) reagent kit.,Wash Buffer(Mindray)-
Mindray Wash Buffer is intended for use with
the CL-series Immunoassay Systems and
specific CL-series immunoassay reagents.
,System Detection Solution(Mindray)-For use
with the CL-series analyzer in system
maintenance.,Sample Diluent(Mindray)-Mindray
Sample Diluent is intended for dilution of
samples in which analyte concentration has
exceeded the measuring range of respective
chemiluminescent immunoassay
reagents.,Thyroid Function Multi Control (L)
(Mindray)-Mindray Thyroid Function Multi
Control is used for quality control by monitoring
the accuracy and precision of Mindray CL-
series Chemiluminescence Immunoassay
Analyzer and test ability of clinical laboratory in
the quantitative measurement of thyroid
function analytes.,Thyroid Function Multi
Control (H)(Mindray)-Mindray Thyroid Function
Multi Control is used for quality control by
monitoring the accuracy and precision of
Mindray CL-series Chemiluminescence
Immunoassay Analyzer and test ability of
clinical laboratory in the quantitative
measurement of thyroid function analytes.,Anti-
thyroid Antibodies Control (L)(Mindray)-Mindray

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Anti-thyroid Antibodies Control is used for
quality control by monitoring the accuracy and
precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of Anti-thyroid
Antibodies analytes.,Anti-thyroid Antibodies
Control (H)(Mindray)-Mindray Anti-thyroid
Antibodies Control is used for quality control by
monitoring the accuracy and precision of
Mindray CL-series Chemiluminescence
Immunoassay Analyzer and test ability of
clinical laboratory in the quantitative
measurement of Anti-thyroid Antibodies
analytes.,Immunoassay Multi Control (L)
(Mindray)-Mindray Immunoassay Multi Control
is used for quality control by monitoring the
accuracy and precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of Immunoassay
Multi analytes.,Immunoassay Multi Control (H)
(Mindray)-Mindray Immunoassay Multi Control
is used for quality control by monitoring the
accuracy and precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of Immunoassay
Multi analytes.,Metabolic Multi Control (L)
(Mindray)-Mindray Metabolic Multi Control is
used for quality control by monitoring the
accuracy and precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of PTH, CT, 25-OH-
Vitamin D Total, VB12, Folate, Ferritin

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
analytes.,Metabolic Multi Control (H)(Mindray)-
Mindray Metabolic Multi Control is used for
quality control by monitoring the accuracy and
precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of PTH, CT, 25-OH-
Vitamin D Total, VB12, Folate, Ferritin
analytes.,ACTH Control (L)(Mindray)-Mindray
ACTH Control is used for quality control by
monitoring the accuracy and precision of
Mindray CL-series Chemiluminescence
Immunoassay Analyzer and test ability of
clinical laboratory in the quantitative
measurement of ACTH analyte.,ACTH Control
(H)(Mindray)-Mindray ACTH Control is used for
quality control by monitoring the accuracy and
precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of ACTH
analyte.,Reproductive Multi Control (L)-Mindray
Reproductive Multi Control is used for quality
control by monitoring the accuracy and
precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of reproductive
hormone analytes.,Reproductive Multi Control
(H)(Mindray)-Mindray Reproductive Multi
Control is used for quality control by monitoring
the accuracy and precision of Mindray CL-
series Chemiluminescence Immunoassay
Analyzer and test ability of clinical laboratory in
the quantitative measurement of reproductive
hormone analytes.,Liver Fibrosis Multi Control

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
(L)(Mindray)-Mindray Liver Fibrosis Multi
Control is used for quality control by monitoring
the accuracy and precision of Mindray CL-
series Chemiluminescence Immunoassay
Analyzer and test ability of clinical laboratory in
the quantitative measurement of Liver Fibrosis
analytes.,Liver Fibrosis Multi Control (H)
(Mindray)-Mindray Liver Fibrosis Multi Control
is used for quality control by monitoring the
accuracy and precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of Liver Fibrosis
analytes.,Laminin (CLIA)(Mindray)-The CL-
series Laminin assay is a Chemiluminescent
Immunoassay (CLIA) for the quantitative
determination of laminin（LN） in human
serum.,Hyaluronic Acid (CLIA)(Mindray)-The
CL-series HA assay is a Chemiluminescent
Immunoassay (CLIA) for the quantitative
determination of hyaluronic acid (HA) in human
serum.,Collagen Type IV (CLIA)(Mindray)-The
CL-series C IV assay is a Chemiluminescent
Immunoassay (CLIA) for the quantitative
determination of Collagen Type IV (C IV) in
human serum.,Procalcitonin (CLIA)(Mindray)-
TheCL-seriesProcalcitonin assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of procalcitonin
（PCT） in human serum or plasma.,PCT
Calibrators(Mindray)-Used in In Vitro
Diagnostics(to calibrate the quantitative
Procalcitonin (PCT) assay on Mindray CL-
series Chemiluminescence Immunoassay
Analyzer).,PCT Control (L)(Mindray)-Used in In
Vitro Diagnostics ( for quality control by

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
monitoring the accuracy and precision of
Mindray CL-series Chemiluminescence
Immunoassay Analyzer and test ability of
clinical laboratory in the quantitative
measurement of PCT).,PCT Control (H)
(Mindray)-Used in In Vitro Diagnostics ( for
quality control by monitoring the accuracy and
precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of PCT).,Hemoglobin
A1c Calibrator(Mindray)-Test and calibrate
HbA1c in whole blood to guarantee that the test
result is accurate,Hemoglobin A1c
Control(Mindray)-Quality control over the test
on HbA1c in whole blood to monitor and assess
the accuracy of the test kit,Prolactin (CLIA)
(Mindray)-The CL-series PRL assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of prolactin (PRL) in
human serum or plasma.,Adrenocorticotropic
hormone (CLIA)(Mindray)-The CL-series ACTH
assay is a Chemiluminescent Immunoassay
(CLIA) for the quantitative determination of
Adrenocorticotropic hormone (ACTH) in human
EDTA plasma.,Anti-Tg Calibrators(Mindray)-
Mindray Anti-Tg Calibrators (Anti-Tg CAL) are
intended to calibrate the quantitative antibody
to thyroglobulin (Anti-Tg) assay on Mindray CL-
series Chemiluminescence Immunoassay
Analyzer.,CK-MB Calibrators(Mindray)-Mindray
CK-MB Calibrators (CK-MB CAL) are intended
to calibrate the quantitative Creatine kinase MB
(CK-MB) assay on Mindray CL-series
Chemiluminescence Immunoassay
Analyzer.,Creatine kinase MB (CLIA)(Mindray)-

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
The CL-series creatine kinase MB assay is a
Chemiluminescent Immunoassay(CLIA) for the
quantitative determination of creatine kinase
MB (CK-MB) in human serum or
plasma,Cortisol Calibrators(Mindray)-Mindray
Cortisol Calibrators (Cortisol CAL) are intended
to calibrate the quantitative Cortisol assay on
Mindray CL-series Chemiluminescence
Immunoassay Analyzer.,Cortisol (CLIA)
(Mindray)-The CL-series Cortisol assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of Cortisol in human
serum, plasma or urine.,C-Peptide
Calibrators(Mindray)-Mindray C-Peptide
Calibrators (C-Peptide CAL) are intended to
calibrate the quantitative C-Peptide assay on
Mindray CL-series Chemiluminescence
Immunoassay Analyzer.,C-Peptide (CLIA)
(Mindray)-The CL-series C-Peptide assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of C-Peptide (C-
Peptide) in human serum, plasma or
urine.,Dehydroepiandrosterone sulfate (CLIA)
(Mindray)-The CL-series DHEA-S assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of
Dehydroepiandrosterone sulfate (DHEA-S) in
human serum or plasma.,Estradiol
Calibrators(Mindray)-Mindray Estradiol
Calibrators (E2 CAL) are intended to calibrate
the quantitative estradiol (E2) assay on Mindray
CL-series Chemiluminescence Immunoassay
Analyzer.,Total T3 Calibrators(Mindray)-Mindray
Total T3 Calibrators (T3 CAL) are intended to
calibrate the quantitative total triiodothyronine
(T3) assay on Mindray CL-series

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Chemiluminescence Immunoassay
Analyzer.,Total Triiodothyronine (CLIA)
(Mindray)-The CL-series T3 assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of total
triiodothyronine (T3) in human serum.,Total T4
Calibrators(Mindray)-Mindray Total T4
Calibrators (T4 CAL) are intended to calibrate
the quantitative total thyroxine (T4) assay on
Mindray CL-series Chemiluminescence
Immunoassay Analyzer.,Total Thyroxine (CLIA)
(Mindray)-The CL-series T4 assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of total thyroxine (T4)
levels in human serum or plasma.,Anti-TPO
Calibrators(Mindray)-Mindray Anti-TPO
Calibrators (Anti-TPO CAL) are intended to
calibrate the quantitative antibodies to thyroid
peroxidase (Anti-TPO) assay on Mindray CL-
series Chemiluminescence Immunoassay
Analyzer.,ACTH Calibrators(Mindray)-Mindray
ACTH Calibrators (ACTH CAL) are intended to
calibrate the quantitative Adrenocorticotropic
hormone (ACTH) assay on Mindray CL-series
Chemiluminescence Immunoassay
Analyzer.,Antibody to thyroglobulin (CLIA)
(Mindray)-The CL-series Anti-Tg assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of Antibody to
thyroglobulin (Anti-Tg) in human serum or
plasma.,Antibody to thyroid peroxidase (CLIA)
(Mindray)-The CL-series Anti-TPO assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination ofAnti-TPO in human
serum or plasma.,Estriol Calibrators(Mindray)-
Mindray Estriol Calibrators (E3 CAL) are

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
intended to calibrate the quantitative estriol (E3)
assay on Mindray CL-series
Chemiluminescence Immunoassay
Analyzer.,Estriol (CLIA)(Mindray)-The CL-series
E3 assay is a Chemiluminescent Immunoassay
(CLIA) for the quantitative determination of
estriol (E3) in human serum.,Estradiol (CLIA)
(Mindray)-The CL-series E2 assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of estradiol (E2) in
human serum.,Ferritin Calibrators(Mindray)-
Mindray Ferritin Calibrators (FERR CAL) are
intended to calibrate the quantitative ferritin
(FERR) assay on Mindray CL-series
Chemiluminescence Immunoassay
Analyzer.,Ferritin (CLIA)(Mindray)-The CL-
series FERR assay is a Chemiluminescent
Immunoassay (CLIA) for the quantitative
determination of ferritin (FERR) in human
serum or plasma,FSH Calibrators(Mindray)-
Mindray FSH Calibrators (FSH CAL) are
intended to calibrate the quantitative follicle
stimulating hormone (FSH) assay on Mindray
CL-series Chemiluminescence Immunoassay
Analyzer.,Follicle Stimulating Hormone (CLIA)
(Mindray)-The CL-series FSH assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of follicle stimulating
hormone (FSH) in human serum or plasma.,M-
58LEO(II) Lyse (Mindray)-M-58 LEO (II) Lyse
applies to Mindray BC-5600 , BC-5800 Auto
Hematology Analyzer. It cooperates with the M-
58 LEO (I) lyse to 4 Differentiate W8C's,M-
58LEO(I) Lyse (Mindray)-M-58 LEO (I) Lyse
applies to Mindray BC-5600 , BC-5800 Auto
Hematology Analyzer. It breaks down red blood

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
cell membrane and cooperates with the M-58
LEO (II) lyse to 4 Differentiate W8C's .,M-
58LBA Lyse (Mindray)-M-58 L8A Lyse applies
to Mindray BC-5600 , 8C-5800 Auto
Hematology Analyzer. It breaks down red blood
cell membrane and 2 differentiates W8C's to
basophils and other W8C's,M-58D Diluent
(Mindray)-M-58 D Diluents applies to Mindray
BC-5600 , BC-5800 Auto Hematology Analyzer.
It provide a stable environment for counting and
sizinq blood cells.,M-53D Diluent(Mindray)-M-
53D diluent provides a stable environment for
counting and sizing blood cells.,M-53 LH
Lyse(Mindray)-M-53LH LYSE breaks down red
blood cell membrane and converts hemoglobin
to a hemoglobin complex to determine the
HGB. It 2-differentiates WBCs to BASo and
other WBCs, and determines WBCs
amount.,M-53 Cleanser (1Lx4)(Mindray)-An-
azide free filtered solution for use in cleaning
Hematology Analyzer,M-52LH Lyse(Mindray)-
M-52 LH Lyse futher process the blood cell that
have been processed by M-52 Diff Lyse. It turns
hemoglobin into methemoglobin, which then
measured by the colorimetric method. It is also
processes W8C's to intensify the difference
between basophiles and other W8C sub
populations and in corporate cytometry to
realize basophil analysis,M-52DIFF
Lyse(Mindray)-M-52 Diff Lyse dissolves RBCs
in the blood cell analysis process. It processes
W8Cs to intensify the difference of the WBC
sub populations and in corporate laser scatter
and flow cytometry to realize diff channel WBC
analysis,M-52D diluent(Mindray)-M-52 D
Diluent proivde stable solution environment for

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No.  License Number  Name  Use  Authority  Class 
blood cells, dilute blood sample, generates
sheath fluid and provide conductance in blood
cell analysis process,M-50P Probe Cleanser
(Mindray)-M-50 P Probe Cleanser applies to
Mindray 5 Part Differential Auto Hematology
Analyzer. It is used to clean the analyzer
regularly,M-50LBA Lyse(Mindray)-M-50 LBA
Lyse applies to Mindray 5 Part Differential Auto
Hematology Analyzer. It is used to lyse red
blood cells and count WBC's and basophils.,M-
50D Diluent (Mindray)-M-50 D Diluents applies
to Mindray 5 Part Differential Auto Hematology
Analyzer. It is used to provide a stable
environment for counting and sizing blood
cells,M-50 LH Lyse(Mindray)-M-50 LH Lyse
applies to 5 Part Differntial Auto Hematology
Analyser. It is used to lyse Red Blood Cells and
Determine the HGB,M-50 LEO (II) Lyse
(Mindray)-M-50 LEO (II) Lyse applies to 5 Part
Differntial Auto Hematology Analyser. It is used
to lyse Red Blood Cells and 4 differentiates
WBC's,M-50 LEO (I) Lyse (Mindray)-M-50 LEO
(I) Lyse applies to 5 Part Differntial Auto
Hematology Analyse_r. It is used to lyse Red
Blood Cells and 4 differentiates WBC's,M-50
Cleanser(Mindray)-M-50 Cleanser applies to
Mindray 5 Part Differential auto Hematolgy
Analyzer. It is an isotonic , cleaning solution use
to clean the analyser,M-30R RINSE(Mindray)-It
is use on Mindray Three part differential
hematology Analyzer. It is use as azide free,
filtered isotonic solution for cleaning
hematology analyser,M30P PROBE
CL(Mindray)-For use on Mindray BC-
3000Plus/BC-3000CT/BC-3200 hematology
analyzer. For use as an azide-free, filtered

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No.  License Number  Name  Use  Authority  Class 
isotonic solution for counting and sizing blood
cells. Use as directed in instrument operator's
manual.,M-30D DILUENT(Mindray)-It is use on
Mindray Three part differential hematology
Analyzer. It is use as azide free, filtered isotonic
solution for counting and sizing of blood
cells,ISE-Urine diluent(Mindray)-ISE Urine
Diluent is intended for use as diluent for Urine
before test on ISE Modules on Mindray BS
Series chemistry analyzers.,Lipase (LIP) kit
(Enzymatic Colorimetric Assay method)
(Mindray)-In Vitro test for the quantitative
determination of LIP concentration in serum or
plasma on photometric system,Lipids
Calibrator(Mindray)-Lipid Calibrator is used for
calibration of quantitative determination of lipid
analytes on Mindray BS measurement
system,Lipoprotein (a) Calibrator(Mindray)-
Lipoportein ( a) Calibrator is used for the
calibration of quantitative determination of lipid
analyte on Mind ray BS measurement
system,Lipoprotein (a) Control N&P(Mindray)-
Lipoprotein (a) N & P is used in lipid analyte
quality control by monitoring accuracy and
precision of Mindray BS measurement system
and test ability of laboratory,M-18CFL
Lyse(Mindray)-For use on Mindray BC-
1800/BC-2800/BC-2600 hematology analyzer.
For use as a cyanide-free lytic reagent for
quantitatively determining hemoglobin and for
counting and sizing leukocytes. Use as directed
in instrument operator's manual.,M-18D
Diluent(Mindray)-For use on Mindray BC-
1800/BC-2800/BC-2600 hematology analyzer.
For use as an azide-free, filtered isotonic
solution for counting and sizing blood cells. Use

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
as directed in instrument operator's manual.,M-
30CFL LYSE(Mindray)-For use on Mindray
three part differential hematology Analyzer For
use as a cyanide free lytic reagent for
quantitatively determining hemoglobin and for
counting and sizing leukocytes,IGM
kit(Mindray)-In Vitro test for the quantitative
determination of IGM Concentration in serum
on photometric system.,Immunoglobulin G
(IgG) Kit (Immunoturbidimetric Method)
(Mindray)-In Vitro test for the quantitative
determination of IGG Concentration in serum
on photometric system,M-53P
Cleanser(Mindray)-M-53P Probe Cleanser
applies to Mindray BC-5300, BC-5380 BC-
5100, BC-5180, ULTIMA 5 Auto Hematology
Analyzer. It is used to clean the analyzer
regularly. Use the M-53P Probe Cleaner as
instructed by the operator’s manual of the
analyzer.,M-53 LEO (II) Lyse(Mindray)-M-
53LEO(II) Lyse cooperates with the M-53LEO(I)
Lyse to 4-differentiate WBCs.,M-53 LEO (I)
Lyse (Mindray)-M-53LEO(I) Lyse breaks down
red blood cell membrane and cooperates with
the M-53LEO(II) Lyse to 4-differentiate
WBCs.,M-18E E-Z Cleanser(Mindray)-For use
on Mindray BC-1800/BC-2800/BC-2600
hematology analyzer. For use as a cleaning
reagent for cleaning hematology analyzer
periodically. Use as directed in instrument
operator's manual.,M-18P Probe
Cleanser(Mindray)-For use on Mindray BC-
1800/BC-2800/BC-2600 hematology analyzer.
For use as a cleaning reagent for hematology
analyzer periodically. Use as directed in
instrument operator's manual.,M-18R

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No.  License Number  Name  Use  Authority  Class 
Rinse(Mindray)-For use on Mindray BC-
1800/BC-2800/BC-2600 hematology analyzer.
For use as an azide-free, filtered isotonic
solution for counting and sizing blood cells. Use
as directed in instrument operator's
manual.,Albumin (ALB) kit (BCG Method)
(Mindray)-In vitro test for the quantitative
determination of ALB concentration in serum
and plasma on photometric system.,Antibodies
Against Streptolysin O (ASO) kit (Particle-
enhanced Immunoturbidimetric Assay Method)
(Mindray)-In Vitro Test for the quantitative
determination of ASO concentration in serum
on photometric system,BC-6D (Mindray)-BC-6D
is an assayed whole blood control designed to
monitor values on multi parameter hematology
cell counters. Please refer to the assay table for
specific instrument models. ,BC-RET(Mindray)-
BC-RET is an assayed whole blood control
designed to monitor values on hematology cell
counters. Please refer to the assay table for
specific instrument models.,Calcium(Ca) kit
(Arsenazo III Method)(Mindray)-In Vitro test for
the quantitative determination of Ca
Concentration in serum,plasma or urine on
photometric system,Carbon dioxide (CO2) kit
(Enzymatic method)(Mindray)-In Vitro test for
the quantitative determination of C02
concentration in serum and heparin plasma on
photometric system,Creatinine Kit (Modified
Jaffe Method)(Mindray)-In vitro test for the
quantitative determination of Creatinine
concentration in serum and plasma on
Photometric system,Direct Bilirubin (D-Bil) Kit
(DSA Method)(Mindray)-In vitro test for the
quantitative determination of D-Bil

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No.  License Number  Name  Use  Authority  Class 
concentration in serum and plasma on
Photometric system,Fructosamine (FUN) kit
(Colorimetric Assay)(Mindray)-In vitro test for
the quantitative determination of fructosamine
concentration in serum, heparin plasma on
photometric systems.,HbA1C Control
N(Mindray)-HbA1c Control N is used in routine
chemistry analytes quality control by monitoring
accuracy and precision of Mindray BS
measurement system and test ability of clinical
laboratory.,HbA1C Control P(Mindray)-HbA1c
Control P is used in routine chemistry analytes
quality control by monitoring accuracy and
precision of Mindray BS measurement system
and test ability of clinical
laboratory.,Hemoglobin A1C (HbA1c) kit
(Enzymatic Method)(Mindray)-In vitro test for
the quantitative determination of HbA1c
concentration in human whole blood on
photometric systems.,Immunoglobulin A (IgA)
Kit (Immunoturbidimetric Method)(Mindray)-In
Vitro test for the quantitative determination of
IGA Concentration in serum on photometric
system,Iron (Fe) kit (Colorimetric Method)
(Mindray)-In Vitro test for the quantitative
determination of Iron in human serum and
heparin plasma on photometric system,CK-MB
Calibrator(Mindray)-CK-MB Calibrator is used
for the calibration of quantitative determination
of cardiac analyte on Mindray BS measurement
system,Cholinesterase (CHE) kit
(Butyrylthiocholine Method)(Mindray)-CHE
Reagent is intended for quantitative
determination of CHE activity in serum or
plasma on photometric system,CD80
Detergent(Mindray)-Clean Sample and

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Reagent Probes, Mixers and Cuvettes of the
Chemistry Analyzer manufactured by
Mindray.,S30 calibrator(Mindray)-S30 Calibrator
is intended for use as calibrator for WBC, RBC,
HGB, MCV and PLT parameters on hematology
analyzers. Before carrying out clinical practice,
parameters of the hematology analyzer need to
be calibrated as instructed in instrument
manual.,Rheumatoid Factor (RF) Kit (Particle-
enhanced Immunoturbidimetric Assay Method)
(Mindray)-In Vitro test for the quantitative
determination of RF concentration in serum on
photometric system,REAGENT, M-30E E-Z
CLEANSER(Mindray)-For use on Mindray BC-
3000/BC-3000Plus/BC-3000CT/ BC-3200
hematology analyzer. For use as a cleaning
reagent for cleaning hematology analyzer
periodically. Use as directed in instrument
operator's manual.,Reagent module (CalA,
CalB, Waste)(Mindray)-For use with the ISE
module daily rinse cleaning diluent,PROBE
CLEANSER (M-68/EN)(Mindray)-Probe
Cleanser applies to Mindray BC-20, BC-21, BC-
10, BC-11, BC-6800, BC-6600, BC-5000, BC-
5150, BC-5390 CRP, BC-5180 CRP, BC-30s,
BC-31s, BC-20s, BC-21s, BC-5120, BC-5130,
BC-5310 CRP, BC-5100 CRP, BC-5140, BC-30,
BC-31, BC-6000, BC-6000Plus, BC-6100, BC-
6100Plus, BC-6200, BC-6600Plus, BC-
6700Plus, BC-6800Plus Auto Hematology
Analyzer, BC-5000Vet Veterinary Auto
Hematology Analyzer, SC-120 Auto Slide Maker
& Stainer and CRP-M100 Specific Protein
Analyzer. It is used to clean the instrument
regularly.,Pre albumin Calibrator(Mindray)-Pre
albumin Calibrator is used for the calibration of

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
quantitative determination of specific proteins
on Mindray BS measurement
system,Phosphorus (P) Kit (Phosphomolybdate
Method)(Mindray)-In Vitro test for the
quantitative determination of P concentration in
serum on photometric system,B55 Control
(Mindray)-B55 Hematology Control is a
hematology reference control used to monitor
the performance of BC series hematology
analyzers. The reference values and expected
ranges of parameters are displayed in the
quality control graphs with upper and lower
control limits. Clinical laboratories use
stabilized, simulated blood cell suspension to
monitor corresponding parameters. Daily use of
this whole blood control provides quality control
data for confirming the precision and accuracy
of instrument. ,V-28R Rinse(Mindray)-An azide-
free filtered isotonic solution for use in blood
cell counting and sizing. Use as directed in
instrument operation manual.,V-28CFL
Lyse(Mindray)-A cyanide Free Lyse Reagent,
Intended for the quantitative determination of
hemoglobin and leukocyte counting and
sizing,M-58 Cleanser (Mindray)-Probe Cleanser
applies to Mindray BC-5600, BC-5800, BC-
3300, BC-3600 Auto Hematology Analyzer. It is
used to clean the analyzer regularly. Use the
Probe Cleaner as instructed by the operator’s
manual of the analyzer. ,Multi Sera
Calibrator(Mindray)-Multi Sera Calibrator is
used for calibration of Quantitative
determination of routine chemistry analystes on
Mindray BS measurement System,ALT
kit(Mindray)-ALT reagent is intended for
quantitative determination of Alanine

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Aminotransferase activity in Serum or plasma
on photometric system.,AST kit(Mindray)-AST
Reagent is intended for quantitative
determination or plasma on photometric system
in serum AST activity,ALP kit(Mindray)-In vitro
test for the quantitative determination of ALP
activity in serum and plasma on photometric
system,GGT kit(Mindray)-GGT reagent is
intended for quantitative determination of
Gamma-Glutamyltransferase activity in human
serum or plasma on photometric systems. ,LDH
kit(Mindray)-LDH reagent is intended for
quantitative determination of Lactate
Dehydrogenase in human serum or plasma on
photometric systems. ,HBDH kit(Mindray)-In
Vitro test for the quantitative determination of a
HBDH activity in serum and plasma on
photometric system,UREA kit(Mindray)-In Vitro
test for the quantitative determination of Urea
concentration in serum, plasma and Urine on
photometric system,T-bil kit(Mindray)-In Vitro
test for the quantitative determination of Bil - T
Concentration in serum and plasma on
photometric system,D-bil kit(Mindray)-In vitro
test for the quantitative determination of Bil-D
concentration in serum and plasma on
Photometric system,CREA kit(Mindray)-In vitro
test for the quantitative determination of
Creatinine concentration in serum and plasma
on Photometric system,CK kit(Mindray)-In vitro
test for the quantitative determination of
Creatinine concentration in serum and plasma
on Photometric system,CK-MB kit(Mindray)-In
vitro test for the quantitative determination of
creatine kinase-MB (CK-MB) activity in serum
on photometric systems.,HDL kit(Mindray)-In

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No.  License Number  Name  Use  Authority  Class 
vitro test for the quantitative determination of
Bil-D concentration in serum and plasma on
Photometric system, LDL kit(Mindray)-In Vitro
test for the quantitative determination of
LDLCholesterol concentration in serum on
photometric system,APOA1 kit(Mindray)-In
Vitro test for the quantitative determination of
ApoA1 Concentration in serum on photometric
system,APOB kit(Mindray)-In Vitro test for the
quantitative determination of ApoB
Concentration in serum on photometric
system,C4 kit(Mindray)-In Vitro test for the
quantitative determination of C4 Concentration
in serum on photometric system,CRP
kit(Mindray)-In Vitro test for the quantitative
determination of CRP Concentration in serum
on photometric system,PA (Mindray)-In vitro
test for the quantitative determination of PA
concentration in serum on photometric
systems. ,LPA kit(Mindray)-In vitro test for the
quantitative determination of Lp(a)
concentration in serum on photometric
systems.,Detergent (Indirect) (International)
(Mindray)-MR Detergent Solution applies to
Mindray BS series auto chemistry analyzers. It
is used to clean the electrodes flow cell as well
as the pipeline of the ISE module. ,Na/K Check
Solution (International)(Mindray)-MR Na/K
Check Solution is a kind of maintenances
solutions used to monitor the
Sodium/Potassium ion-selective performance of
ion-selective electrode installed in ISE Modules
on automatic chemistry analyzers. ,BC-5D
((High/Normal/Low)*2/EN3mL*6)(Mindray)-BC -
5D is an assayed whole blood control designed
to monitor values on multi parameter

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
hematology cell counters,V-52D Diluent
(EN/20L×1)(Mindray)-V-52D diluent applies to
BC-5000Vet Veterinary Auto Hematology
Analyzer manufactured by Mindray, it is used in
sample dilution, blood cell counting, volume
measurement and hemoglobin
measurement.,V-52DIFF LYSE (EN/300mL×4)
(Mindray)-V-52DIFF applies to BC-5000Vet
Veterinary Auto Hematology Analyzer
manufactured by Mindray, it dissolves RBCs
and differentiates WBCs.,V-52LH LYSE
(EN/90mL×4)(Mindray)-V-52LH Lyse applies to
BC-5000Vet Veterinary Auto Hematology
Analyzer manufactured by Mindray, it dissolves
RBCs, realizes WBC counting, basophil
differential and hemoglobin measurement.,V-
28D DILUENT(Mindray)-An azide-free filtered
isotonic solution for use in blood cell counting
and sizing. Use as directed in instrument
operation manual.,V-28E E-Z CLEAN(Mindray)-
intended for cleaning the hematology analyzer
periodically. Use as directed in instrument
operation manual.,V28P PROBE CL(Mindray)-
intended for cleaning the hematology analyzer
periodically. Use as directed in instrument
operation manual.,KIT,CLEANING SOLUTION,
ISE(Mindray)-intended for cleaning the
chemistry analyzer ,-Amylase (-Amy) Kit (IFCC
Method)(Mindray)-α-AMY reagent is intended for
quantitative determination of a Amylase activity
in serum. plasma or urine on photometric
system,Uric acid (UA) Kit (Uricase-Peroxidase
Method)(Mindray)-In Vitro test for the
quantitative determination of UA concentration
in serum, plasma and Urine on photometric
system,Triglycerides (TG) Kit (GPO-POD

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No.  License Number  Name  Use  Authority  Class 
Method)(Mindray)-In Vitro test for the
quantitative determination of TG concentration
in serum and plasma on photometric
system,Total Protein (TP) Kit (Biuret Method)
(Mindray)-In Vitro test for the quantitative
determination of TP concentration in serum and
plasma on photometric system,Total
Cholesterol (TC) Kit (CHOD-POD Method)
(Mindray)-In Vitro test for the quantitative
determination of TC concentration in serum and
plasma on photometric system,Total Bilirubin
(T-Bil) Kit (DSA Method)(Mindray)-In Vitro test
for the quantitative determination of Bil - T
Concentration in serum and plasma on
photometric system,Total Bile Acids (TBA) Kit
(Enzymatic cycling assay)(Mindray)-In Vitro test
.for the quantitative determination of total Bile
acid concentration in serum and plasma on
photometric system,Specific Proteins
Calibrator(Mindray)-Specific proteins calibrator
is used for the calibration of quantitative
determination of specific proteins on Mindray
BS measurement system,SC-CAL PLUS
calibrator(Mindray)-SC CAL PLUS is designed
for use in the calibration of hematology
analyzer,Multi Control Sera P(Mindray)-Multi
Control Sera P is used in routine chemistry
analytes quality control by monitoring accuracy
and precision on Mindray BS measurement
system and test ability of laboratory,Multi
Control Sera N(Mindray)-Multi Control Sera N is
used in routine chemistry analytes quality
control by monitoring accuracy and precision on
Mindray BS measurement system and test
ability of laboratory,MR Urine
Standard(Mindray)-MR Urine Standard is

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No.  License Number  Name  Use  Authority  Class 
intended for use as calibrator for in vitro testing
for the quantitative determination of sodium,
potassium, and chloride concentration in urine
sample on ion-selective electrode on ISE
Modules on BS series automatic chemistry
analyzers. Before carrying out clinical practice,
parameters of the chemistry analyzer need to
be calibrated as instructed in instrument
manual.,MR Urine Quality Control(Mindray)-MR
Urine Quality Control is an electrolyte reference
urine control used to monitor the urine mode
performance of ion-selective electrode on ISE
Modules on automatic chemistry analyzers.
Daily use of this urine control provides quality
control data for confirming the precision and
accuracy of urine sample tests. ,MR Serum
Standard(Mindray)-R Serum Standard is
intended for use as calibrator for in vitro testing
for the quantitative determination of sodium,
potassium, and chloride concentration in serum
and plasma sample on ion-selective electrode
on ISE Modules on BS series automatic
chemistry analyzers). Before carrying out
clinical practice, parameters of the chemistry
analyzer need to be calibrated as instructed in
instrument manual.,MR Buffer
Solution(Mindray)-MR Buffer Solution applies to
Mindray BS series auto chemistry a nalyzers. It
is used to dilute samples before they are
disposed to the electrodes flowcell. Use the MR
Buffer Solution as instructed by the operator's
manual of t he analyzer.,Magnesium (Mg) Kit
(Xylidyl blue Method)(Mindray)-In Vitro test for
the quantitative determination of Mg
concentration in serum, plasma and urine on
photometric system,M-68LN lyse(Mindray)-The

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No.  License Number  Name  Use  Authority  Class 
M-68LN LYSE applies to Mindray BC-6800/BC-
6600 Auto Hematology Analyzer. It participates
in the measurement of NRBC-related
parameters together with M-68FN DYE.,M-
68LH lyse(Mindray)-The M-68LH LYSE applies
to Mindray BC-6800/BC-6600 Auto Hematology
Analyzer. It is formulated to measure the
hemoglobin-related parameters,M-68LD
lyse(Mindray)-The M-68LD LYSE applies to
Mindray BC-6800/BC-6600 Auto Hematology
Analyzer. It participates in WBC differentiation
in the DIFF channel together with M-68FD
DYE.,M-68LB lyse(Mindray)-The M-68LB LYSE
applies to Mindray BC-6800/BC-6600 Auto
Hematology Analyzer. It participates in WBC
counting and measurement of basophil-related
parameters.,M-68FR DYE(Mindray)-The M-
68FR DYE applies to Mindray BC-6800/BC-
6600 Auto Hematology Analyzer. It participates
in the measurement of RET-related parameters
together with M-68DR DILUENT.,M-68FN
DYE(Mindray)-The M-68FN DYE applies to
Mindray BC-6800/BC-6600 Auto Hematology
Analyzer. It participates in the measurement of
NRBC-related parameters together with M-
68LN LYSE.,M-68FD DYE(Mindray)-The M-
68FD DYE applies to Mindray BC-6800/BC-
6600 Auto Hematology Analyzer. It participates
in WBC differentiation in the DIFF channel
together with M-68LD LYSE,M-68DS
Diluent(Mindray)-The M-68DS DILUENT
applies to Mindray BC-6800/BC-6600 Auto
Hematology Analyzer. It participates in the
measurement of parameters related to RBC,
PLT, WBC, RET and NRBC. M-68DS DILUENT
also applies to SC-120 Auto Slide Maker &

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Stainer and CRP-M100 Specific Protein
Analyzer manufactured by Mindray. It
participates in the cleaning of related
components of the Auto Slide Maker & Stainer
and Specific Protein Analyzer.,M-68DR
Diluent(Mindray)-The M-68DR DILUENT
applies to Mindray BC-6800/BC-6600 Auto
Hematology Analyzer. It participates in the
measurement of RET-related parameters
together with M-68FR DYE.,M-58LH Lyse -M-
58 LH Lyse applies to Mindray BC-5600 , BC-
5800 Auto Hematology Analyzer. It breaks
down red blood cell membrane and converts
hemoglobin to a hemoglobin complex to
determine the HG8.,Complement C3 Kit
(Immunoturbidimetric Method)(Mindray)-In Vitro
test for the quantitative determination of C3
Concentration in serum on photometric system

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No.  License Number  Name  Use  Authority  Class 

1023 IMP/IVD/2020/000469 ASPEN Troponin I Calibrators(Mindray)-Mindray CDSCO Class C

DIAGNOSTICS PVT. Troponin I Calibrators (TnI CAL) are intended to
LTD. calibrate the quantitative Troponin I (TnI) assay
on Mindray CL-series Chemiluminescence
Immunoassay Analyzer.,CA125
Calibrators(Mindray)-Mindray CA125
Calibrators (CA125 CAL) are intended to
calibrate quantitative Cancer Antigen 125
(CA125) assay on the Mindray CL-series
Chemiluminescence Immunoassay
Analyzer.,BNP Calibrators(Mindray)-Mindray
BNP Calibrators (BNP CAL) are intended to
calibrate the quantitative B-type natriuretic
peptide (BNP) assay on Mindray CL-series
Chemiluminescence Immunoassay
Analyzer,Cardiac Marker Multi Control (H)
(Mindray)-Mindray Cardiac Marker Multi Control
is used for quality control by monitoring the
accuracy and precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of Cardiac Marker
analytes.,Alfa-fetoprotein (CLIA)(Mindray)-The
CL-series AFP assay is a Chemiluminescent
Immunoassay (CLIA) for the quantitative
determination of alpha-fetoprotein (AFP) in
human serum or plasma.,AFP
Calibrators(Mindray)-Mindray AFP Calibrators
(AFP CAL) are intended to calibrate the
quantitative Alpha-fetoprotein (AFP) assay on
Mindray CL-series Chemiluminescence
Immunoassay Analyzer.,Tumor Marker Control
II (L)(Mindray)-Mindray Tumor Marker Multi
Control is used for quality control by monitoring
the accuracy and precision of Mindray CL-
series Chemiluminescence Immunoassay
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No.  License Number  Name  Use  Authority  Class 
Analyzer and test ability of clinical laboratory in
the quantitative measurement of tumor marker
analytes.,Troponin I (CLIA)(Mindray)-The CL-
series TnI assay is a Chemiluminescent
Immunoassay (CLIA) for the quantitative
determination of TnI in human serum or
plasma.,B-type natriuretic peptide (CLIA)
(Mindray)-The CL-series BNP assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of B-type natriuretic
peptide (BNP) in human EDTA plasma.,Total
PSA Calibrators(Mindray)-Mindray Total PSA
Calibrators (t-PSA CAL) are intended to
calibrate the quantitative total prostate specific
antigen (t-PSA) assay on Mindray CL-series
Chemiluminescence Immunoassay
Analyzer.,Total Prostate Specific Antigen (CLIA)
(Mindray)-The CL-series t-PSA assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of total prostate
specific antigen (total PSA, t-PSA) in human
serum or plasma.,Tumor Marker Control II (H)
(Mindray)-Mindray Tumor Marker Multi Control
is used for quality control by monitoring the
accuracy and precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of tumor marker
analytes.,Cancer Antigen 125 (CLIA)(Mindray)-
The CL-series CA125 assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of cancer antigen
125 (CA125) in human serum or plasma.,CEA
Calibrators(Mindray)-Mindray CEA Calibrators
(CEA CAL) are intended to calibrate the
quantitative carcinoembryonic antigen (CEA)

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No.  License Number  Name  Use  Authority  Class 
assay on Mindray CL-series
Chemiluminescence Immunoassay
Analyzer.,Cardiac Marker Multi Control (L)
(Mindray)-Mindray Cardiac Marker Multi Control
is used for quality control by monitoring the
accuracy and precision of Mindray CL-series
Chemiluminescence Immunoassay Analyzer
and test ability of clinical laboratory in the
quantitative measurement of Cardiac Marker
analytes.,Carcinoembryonic Antigen (CLIA)
(Mindray)-The CL-series CEA assay is a
Chemiluminescent Immunoassay (CLIA) for the
quantitative determination of carcinoembryonic
antigen (CEA) in human serum or plasma.

1024 IMP/IVD/2020/000470 Siemens Healthcare NUCLISWAB(NUCLISWAB)-Nucliswab is a CDSCO Class B

Private Limited transport system used for collection and
transport of cells from clinical samples or from
environment, for isolation of nucleic acids that
will be used in nucleic acid amplification tests.

1025 IMP/IVD/2020/000471 Imperial Life Sciences SARS-CoV-2 Fluorescent PCR(MACCURA)- CDSCO Class C
Pvt. Ltd. For in vitro qualitative detection of SARS-CoV-2
(also known as 2019-nCoV) ORF1ab, E, and N
gene in oropharyngeal swabs and sputum
specimens of suspected SARS-CoV-2-infected
pneumonia cases, suspected clustered
infection cases, and others who need SARS-
CoV-2 infection diagnosis or differential
diagnosis.,Mag-Bind RNA Extraction
Kit(MACCURA)-For extraction, enrichment,
purification and other steps of nucleic acid
which is used for in vitro clinical tests.

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No.  License Number  Name  Use  Authority  Class 

1026 IMP/IVD/2020/000474 POINT OF CARE Hemoglobin A1c Reagent Kit(Skyla Hi CDSCO Class B
BIOMEDICAL PVT. Hemoglobin A1c Reagent Kit)-The skylaTM Hi
LTD. Hemoglobin A1c Reagent kit is an
immunoassay used with skylaTM Hi Analyzer
provides quantitative measurement of the
percent concentration of glycated hemoglobin
(%HbA1c) in both of capillary blood taken from
the finger-prick, and venous whole
blood.,Lipid/Glu Panel(Skyla Hi Lipid/Glu
Panel)-he skyla Hi Lipid Panel PLUS used with
skyla Hi Analyzer is intended to be used for the
quantitative determination of Blood Glucose
(GLU), High-Density Lipoprotein (HDL), Total
Cholesterol (TC), and Triglyceride (TG) in both
of finger-prick whole blood, venous whole
blood, Plasma or Serum.

1027 IMP/IVD/2020/000474 POINT OF CARE CRP Reagent Kit(Skyla Hi CRP Reagent Kit)- CDSCO Class C
BIOMEDICAL PVT. The skyla Hi CRP reagent kit is an
LTD. immunoassay used with skyla Hi Analyzer
provides quantitative measurement of C-
Reactive Protein (CRP) concentration in human
serum, plasma, and whole blood.

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No.  License Number  Name  Use  Authority  Class 

1028 IMP/IVD/2020/000476 Invitrogen Bioservices 5X MAGMAX PATHOGEN RNA/DNA CDSCO Class C

India Pvt. Ltd. KIT(Applied Biosystems)-The Applied
Biosystems® MagMAX™ Pathogen RNA/DNA
Kit enables purification of RNA and DNA from
viruses and easy-to-lyse bacteria and parasites,
using magnetic particle technology in a 96-well
format.,MAGMAX VIRAL/PATHOGEN BULK
KIT 1000 PREPS(Applied Biosystems)-The
MagMAX Viral/Pathogen Nucleic Acid Isolation
Kit is designed to recover RNA and DNA from
virus and gram-negative bacteria in samples
such as blood, swabs, urine, and viral transport
media (VTM).,MagMAX™ Viral/Pathogen II
(MVP II) Nucleic Acid Isolation Kit 2,000
PREPS(Applied Biosystems)-The MagMAX™
Viral/Pathogen II Nucleic Acid Isolation Kit is a
nucleic acid purification kit based on magnetic
bead technology. The kit is intended for the
isolation and purification of viral nucleic acids
from human nasopharyngeal swabs and viral
RNA from saliva specimens, and is suitable for
use in molecular detection by qPCR.,TaqMan®
Fast Virus 1-Step Master Mix(Applied
Biosystems)-The TaqMan® Fast Virus 1-Step
Master Mix can be used with any TaqMan®
primer and probe set for real-time RT-PCR of
DNA and RNA samples. During thermal cycling,
the reverse transcription step does not affect
performance with DNA targets.

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No.  License Number  Name  Use  Authority  Class 

1029 IMP/IVD/2020/000477 V S Yarns Private Acco COVID-19 IgM/IgG Rapid Test(Acco CDSCO Class C
Limited COVID-19 IgM/IgG Rapid Test)-Acco COVID-
19 IgM/IgG device is a chromatographic
immunoassay kit for the rapid and differential
detection of immunoglobulin M (lgM) and
immunoglobulin G (IgG) against COVID- 19
using serum, plasma and whole blood

1030 IMP/IVD/2020/000478 Invitrogen Bioservices MAGMAX VIRAL/PATHOGEN KIT(Applied CDSCO Class C

India Pvt. Ltd. Biosystems)-The Applied Biosystems™
MagMAX™ Viral/Pathogen Nucleic Acid
Isolation Kit is developed for scalable, rapid
purification of high quality nucleic acid (RNA
and DNA) from virus and easy to lyse bacteria
in biofluid and transport media samples.

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No.  License Number  Name  Use  Authority  Class 

1031 IMP/IVD/2020/000479 M/s Hemogenomics Procleix Ultrio Plus Assay Kit (A qualitative In- CDSCO Class D
Private Limited Vitro nucleic acid amplification test for the
detection of HIV 1 RNA, HCV RNA and HBV
DNA in plasma and serum specimens from
human donors)(Procleix Ultrio Plus)-The
Procleix Ultrio Plus Assay is a qualitative in vitro
nucleic acid amplification test for the detection
of human immunodeficiency virus type 1 (HIV-
1) RNA, hepatitis C virus (HCV) RNA, and/or
hepatitis B virus (HBV) DNA in plasma and
serum specimens from human donors, tested
individually or in pools. It is also intended for
use in testing plasma and serum to screen
organ and tissue donors, including cadaveric
(non-heart-beating) donors,Procleix Ultrio Elite
Assay Kit (A qualitative In-Vitro nucleic acid
amplification test for the detection of HIV 1 & 2
RNA, HCV RNA and HBV DNA in plasma and
serum specimens from human donors)(Procleix
Ultrio Elite )-The Procleix Ultrio Elite Assay is a
qualitative in vitro nucleic acid amplification test
for the detection of human immunodeficiency
virus type 1 and human immunodeficiency virus
type 2 (HIV) RNA, hepatitis C virus (HCV) RNA,
and/or hepatitis B virus (HBV) DNA in plasma
and serum specimens from human donors,
tested individually or in pools. It is also intended
for use in testing plasma and serum to screen
organ and tissue donors, including cadaveric
(nonheart- beating) donors.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1032 IMP/IVD/2020/000481 DEEP MEDITECH Auto Blood Culture Detection System-For CDSCO Class A
PVT. LTD. qualitative and/or quantitative in vitro
determination of microorganism growth in a
blood culture preparation or any other clinical
specimen, with or without subsequent
identification of the organism.,Auto microbial
identification and antimicrobial susceptibility
testing system-For in vitro determination of an
antimicrobial susceptibility profile by monitoring
the growth rate of a microbiological organism
from a clinical specimen and/or culture isolate
when exposed to a range of antimicrobials.

1033 IMP/IVD/2020/000481 DEEP MEDITECH IST Card-Used for identification and CDSCO Class B
PVT. LTD. antimicrobial MIC determinations,Aerobic Blood
Culture Bottle-Used for qualitative detection of
microbial in human blood or other body fluids
under normal sterile conditions,Children’s Blood
Culture Bottle-Used for qualitative detection of
microbial in human blood or other body fluids
under normal sterile conditions,Anaerobic
Blood Culture Bottle-Used for qualitative
detection of microbial in human blood or other
body fluids under normal sterile conditions

1034 IMP/IVD/2020/000482 GENAXY SCIENTIFIC DNA & RNA Isolation Kits(FAVORGEN)-FOR CDSCO Class C
PVT LTD ISOLATION OF DNA & RNA FROM VARIOUS
SAMPLES

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1035 IMP/IVD/2020/000483 BYUNGMAN COVID-19 real-time RT-PCR Kit(PaxView)-The CDSCO Class C

ELECTRIC PRIVATE PaxView® COVID-19 real-time RT-PCR Kit
LIMITED detects the novel coronavirus, COVID-19 using
one-step realtime RT-PCR in a single tube. The
target genes for the detection of the virus are
Orf1ab and N gene. The sequence of primers
and probes for the amplification were adapted
from sources published by China CDC and
WHO.We recommend use viral RNA extracted
from oropharyngeal swab, nasopharyngeal
swab, sputum and bronchoalveolar
lavage(BAL) sample.

1036 IMP/IVD/2020/000484 INBIOS INDIA STAT-NAT® COVID-19 HK-The STAT-NAT® CDSCO Class C
COVID-19 HK kit is a lyophilized Real-time RT-
PCR qualitative assay based on nucleic acid
amplification for the identification of the novel
Coronavirus SARS-CoV-2 RNA in human
respiratory tract specimens

1037 IMP/IVD/2020/000485 DEEP MEDITECH SARS-CoV-2 Nucleic Acid Detection Kit (PCR- CDSCO Class C
PVT. LTD. Fluorescent Probe Method)-For detection of
SARS-CoV-2 RNA in sputum, throat swab,
alveolar lavage fluids specimens

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1038 IMP/IVD/2020/000486 LAB X Triglycerides(LAB KIT)-Chemelex LABKIT CDSCO Class B

brand TRIGLYCERIDES in intended for the
quantitative in vitro diagnostics determination of
triglycerides. ,Triglycerides-LS(LAB KIT)-
Chemelex LABKIT brand TRIGLYCERIDES in
intended for the quantitative in vitro diagnostics
determination of Triglycerides. ,Urea-UV-
LQ(LAB KIT)-Chemelex LABKIT brand UREA
UV-LQ in intended for the quantitative in vitro
diagnostics determination of Urea. ,CK-MB
LQ(LAB KIT)-Chemelex LABKIT brand CK-MB
LQ in intended for the quantitative in vitro
diagnostics determination of ck-mb.
,Chloride(LAB KIT)-Chemelex LABKIT brand
CHLORIDE in intended for the quantitative in
vitro diagnostics determination of chloride.
,LDH-LQ(LAB KIT)-Chemelex LABKIT brand
LDH-LQ in intended for the quantitative in vitro
diagnostics determination of lactate
dehydrogenase (LDH). ,Lactate-LQ(LAB KIT)-
Chemelex LABKIT brand LACTATE in intended
for the quantitative in vitro diagnostics
determination of lactate. ,Iron-FZ(LAB KIT)-
Chemelex LABKIT brand Iron-FZ in intended
for the quantitative in vitro diagnostic
determination of iron. ,ALP LQ(LAB KIT)-
Chemelex LABKIT brand ALP-LQ in intended
for the quantitative in vitro diagnostics
determination of alkaline phosphatase
(ALP),GPT/ALT-LQ(LAB KIT)-Chemelex
LABKIT brand GPT/ALT-LQ in intended for the
quantitative in vitro diagnostics determination of
GPT/ALT. ,Albumin(LAB KIT)-Chemelex
LABKIT brand ALBUMIN in intended for the
quantitative in vitro diagnostics determination of
albumin.,GOT/AST-LQ(LAB KIT)-Chemelex
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
LABKIT brand GOT/AST-LQ in intended for the
quantitative in vitro diagnostics determination of
GOT/AST. ,Bilirubin T-DMSO(LAB KIT)-
Chemelex LABKIT brand Bilirubin T-DMSO in
intended for the quantitative in vitro diagnostic
determination of Direct Bilirubin. ,Gamma-GT-
LQ(LAB KIT)-Chemelex LABKIT brand -GT
LQ in intended for the quantitative in vitro
diagnostics determination of gamma-glutamyl
transferase (-GT) ,Bilirubin D-DMSO(LAB
KIT)-Chemelex LABKIT brand Bilirubin D-
DMSO in intended for the quantitative in vitro
diagnostic determination of Direct Bilirubin.
,CK-NAC LQ(LAB KIT)-Chemelex LABKIT
brand CK-NAC LQ in intended for the
quantitative in vitro diagnostics determination of
ck-nac. ,Cholesterol LS(LAB KIT)-Chemelex
LABKIT brand Cholesterol LS in intended for
the quantitative in vitro diagnostic determination
of cholesterol. ,Calcium-AIII(LAB KIT)-
Chemelex LABKIT brand Calcium-AIII in
intended for the quantitative in vitro diagnostic
determination of calcium. ,Bilirubin T&D-
DMSO(LAB KIT)-Chemelex LABKIT brand
Bilirubin T&D-DMSO in intended for the
quantitative in vitro diagnostic determination of
Direct and Total Bilirubin. ,IgM(LAB KIT)-
Chemelex LABKIT brand IgM in intended for
IVD human Immunoglobulin M (IgM) ,IgG(LAB
KIT)-Chemelex LABKIT brand IgG in intended
for IVD human Immunoglobulin G (IgG) ,Total
Proteins(LAB KIT)-Chemelex LABKIT brand
Total Protein in intended for the quantitative in
vitro diagnostic determination of total proteins.
,Total Lipids(LAB KIT)-Chemelex LABKIT brand
Total Lipids in intended for the quantitative in

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
vitro diagnostic determination of Total Lipids.
,Magnesium(LAB KIT)-Chemelex LABKIT
brand MAGNESIUM in intended for the
quantitative in vitro diagnostics determination of
magnesium.,Phosphorus-UV(LAB KIT)-
Chemelex LABKIT brand Phosphorus-UV in
intended for the quantitative in vitro diagnostic
determination of Phosphorus. ,Microalbumin-
Turbi(LAB KIT)-Chemelex LABKIT brand
MICROALBUMIN TURBI in intended for IVD
quantitative measure the microalbumin.,Lp(a)
Turbi(LAB KIT)-Chemelex LABKIT brand Lp(a)
TURBI in intended for IVD quantitative measure
the Lp(a). ,CO2 LQ(LAB KIT)-Chemelex
LABKIT brand CO2 LQ in intended for the
quantitative in vitro diagnostics determination of
carbon dioxide.,PROT-CAL(LAB KIT)-
Chemelex Labkit brand PROT-CAL in intended
for IVD quantitative determination of Proteins
(PROT),IgA(LAB KIT)-Chemelex LABKIT brand
IgA in intended for IVD human Immunoglobulin
A (IgA) ,IgE-Turbi(LAB KIT)-Chemelex LABKIT
brand IgE TURBI in intended for IVD
quantitative measure the IgE. ,Uric Acid-
LS(LAB KIT)-Chemelex LABKIT brand URIC
ACID LS in intended for the quantitative in vitro
diagnostics determination of Uric acid.
,Creatinine-J(LAB KIT)-Chemelex LABKIT
brand Creatinine-J in intended for the
quantitative in vitro diagnostic determination of
Creatinine. ,Cholesterol(LAB KIT)-Chemelex
LABKIT brand CHOLESTEROL in intended for
the quantitative in vitro diagnostics
determination of cholesterol.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1039 IMP/IVD/2020/000486 LABX ,T.C.95/2004(1) ASO LATEX KIT(LABKIT)-QUANTITATIVE CDSCO Class B

& T.C.95/2004(2), DETERMINATION OF ASO IN HUMAN
GROUND & FIRST SAMPLES,Labtrol H Normal(LABKIT)-
FLOOR,DEV LABTROL NORMAL IS MULTI PARAMETRIC
ATRIUM,PADINJATTIL CONTROL SERA INTENDED FOR
LANE, ACCURACY CONTROL OF LABKIT CLINICAL
KUMARAPURAM, CHMISTRY REAGENTS.THE
MEDICAL COLLEGE- CONCENTRATION & ACTIVITIES ARE IN THE
P.O NORMAL RANGE OR AT THE NORMAL
,Thiruvananthapuram THRESHOLD (BOVINE SOURCE).,Protein U &
Kerala ,695011 ,India CSF(LABKIT)-QUANTITATIVE
DETERMINATION OF TOTAL URINARY &
CSF PROTEIN IN HUMAN SAMPLES.,Lipase -
LQ(LABKIT)-Quantitative determination of the
lipase activity in human samples.,APO
B(LABKIT)-Quantitative determination of
human apolipoprotein B (Apo B),APO
A1(LABKIT)-Quantitative determination of
human apolipoprotein A1 (Apo A1),CHE
Cholinsterase(LABKIT)-Quantitative
determination of the cholinesterase activity in
human samples.,CRP LATEX KIT(LABKIT)-
QUANTITATIVE DETERMINATION OF C-
REACTIVE PROTEIN IN HUMAN
SAMPLES,Complement C3(LABKIT)-
Quantitative determination of Complement C3
in human samples,APO - CAL(LABKIT)-Serum
calibrator for APO A1/B turbidimetry
assay,Complement C4(LABKIT)-Quantitative
determination of Complement C4 in human
samples,HDLc-D(LABKIT)-QUANTITATIVE
DETERMINATION OF CHOLESTEROL HDL IN
HUMAN SAMPLES,LDLc-D(LABKIT)-
QUANTITATIVE DETERMINATION OF
CHOLESTROL LDL IN HUMAN
SAMPLES,TIBC(LABKIT)-quantitative
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
determination of IRON TIBC IN HUMAN
SAMPLES.,LABTROL H
PATHOLOGICAL(LABKIT)-labtrol pathological
is multi parametric control sera intended for
accuracy control of labkit clinical chemistry
reagents. the concentration and activities are in
the pathological range (bovin
source),LABTROL H CAL(LABKIT)-Labtrol H
Calibrator is multi parametric calibrator
intended for accuracy calibration of Labkit
reagents (Bovine Source).,AMYLASE-
LQ(LABKIT)-QUANTITATIVE
DETERMINATION OF THE ALPHA AMYLASE
ACTIVITY IN HUMAN SAMPLES,ACP Acid
Phosphatase(LABKIT)-Quantitative
determination of acid phosphatase (ACP)
activity in human samples.,CRP-
TURBI(LABKIT)-QUANTITATIVE
DETERMINATION OF C REACTIVE PROTEIN
IN HUMAN SAMPLES.,RF - TURBI(LABKIT)-
QUANTITATIVE DETERMINATION OF
RHEUMATID FACTOR IN HUMAN
SAMPLES.,ASO- TURBI(LABKIT)-
QUANTITATIVE DETERMINATION OF ASO IN
HUMAN SAMPLES,RF LATEX KIT(LABKIT)-
QUALITATIVE DETERMINATION OF
RHEUMATID FACTOR IN HUMAN IN HUMAN
SAMPLE

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1040 IMP/IVD/2020/000488 ALPHA AGENCIES RNA/DNA EXTRACTION KIT(Patho Gene-Spin CDSCO Class C
Viral DNA/RNA EXTRACTION KIT)-Pathogen
detection, PCR, RT-PCR, Quantitative PCR
(qPCR, qRT- PCR),RT PCR KIT(LILIF COVID
19 Real Time RT PCR KIT)-Sputum,
bronchoalveolar lavage fluid (BAL) in patients
with suspected respiratory infections, or nasoph
aryngeal swab (NS) and oropharyngeal swab
(OS) collected simultaneously in the upper
respiratory trac t In vitro diagnostic medical
device that helps to diagnose new coronavirus
infection (COVID-19) by qualitatively detecting
genes (RdRP gene, E gene, and N gene) of
new coronavirus (2019-nCoV) from the sample.

1041 IMP/IVD/2020/000489 Q-Line Biotech Private Three Part Hematology Analyzer(Swelab)-Used CDSCO Class A
Limited in In-vitro Diagnostics,Five Part Hematology
Analyzer(Medonic )-Used in In-vitro Diagnostics
,Three Part Hematology Analyzer(Medonic)-
Used in Invitro Diagnostics

1042 IMP/IVD/2020/000489 POCT Services Private Medonic Diluent (Medonic M51-D Diluent 20 L)- CDSCO Class B
Limited Used in In-Vitro Diagnostic,Medonic Lyse L-
2(Medonic M51 Lyse L-2 500 ml)-Used in In-
Vitro Diagnostic,Easy Cleaner (Boule Easy
Cleaner )-Used in In-Vitro Diagnostic ,Medonic
Lyse L-1(Medonic M51 Lyse L-1 200 ml)-Used
in In-Vitro Diagnostic

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1043 IMP/IVD/2020/000490 Cepheid India Pvt Ltd Xpert Xpress Flu/RSV(Xpert Xpress Flu/RSV)- CDSCO Class C
real-time, reverse transcriptase polymerase
chain reaction (RT-PCR) assay intended for the
in vitro qualitative detection and differentiation
of influenza A, influenza B, and respiratory
syncytial virus (RSV) viral RNA. The Xpert
Xpress Flu/RSV Assay uses nasopharyngeal
(NP) swab and nasal swab (NS) specimens
collected from patients with signs and
symptoms of respiratory infection. The Xpert
Xpress Flu/RSV Assay is intended as an aid in
the diagnosis of influenza and respiratory
syncytial virus infections in conjunction with
clinical and epidemiological risk factors.
Negative results do not preclude influenza virus
or RSV infection and should not be used as the
sole basis for treatment or other patient
management decisions. Performance
characteristics for influenza A were established
during the 2015-2016 influenza season for NP
swab specimens and the 2016-2017 influenza
season for NS specimens. When other novel
influenza A viruses are emerging, performance
characteristics may vary. If infection with a
novel influenza A virus is suspected based on
current clinical and epidemiological screening
criteria recommended by public health
authorities, specimens should be collected with
appropriate infection control precautions for
novel virulent influenza viruses and sent to
state or local health departments for testing.
Viral culture should not be attempted in these
cases unless a BSL 3+ facility is available to
receive and culture specimens.,Xpert Xpress
CoV-2/Flu/RSV Plus(Xpert Xpress CoV-
2/Flu/RSV Plus)-The Xpert Xpress CoV -
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
2/Flu/RSV plus test, performed on the
GeneXpert Instrument Systems, is a
multiplexed real – time RT - PCR test intended
for use in the simultaneous in vitro qualitative
detection and differentiation of RNA from SARS
CoV - 2, influenza A, influenza B, and/or
respiratory syncytial virus (RSV) in
nasopharyngeal swab or anterior nasal swab
specimens collected from individuals with signs
and/or symptoms of respiratory viral infection.
SARS-CoV-2, influenza A, influenza B and RSV
RNA identified by this test are generally
detectable in upper respiratory specimens
during the acute phase of infection. Positive
results are indicative of the presence of the
identified virus, but do not rule out bacterial
infection or co-infection with other pathogens
not detected by the test. Clinical correlation with
patient history and other diagnostic information
is necessary to determine patient infection
status. The agent detected may not be the
definite cause of disease. Negative results do
not preclude SARS-CoV-2, influenza A virus,
influenza B virus and/or RSV infection and
should not be used as the sole basis for
treatment or other patient management
decisions. Negative results must be combined
with clinical observations, patient history, and/or
epidemiological information

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1044 IMP/IVD/2020/000490 Cepheid India Pvt Ltd Xpert Xpress SARS-COV-2(Xpert Xpress CDSCO Class C
,9th Floor, Tower B, SARS-COV-2)-The Xpert Xpress SARS-CoV-2
Paras Twin Towers, test is a rapid, real-time RT-PCR test intended
Golf Course Road, for the qualitative detection of nucleic acid from
Sector-54, Gurugram the SARS-CoV-2 in upper respiratory
,Gurgaon Haryana specimens (such as nasopharyngeal,
,122002 ,India oropharyngeal, nasal, or mid-turbinate swab
and/or nasal wash/ aspirate) collected from
individuals suspected of COVID-19 by their
healthcare provider. Testing of nasopharyngeal,
oropharyngeal, nasal, or mid-turbinate swab
and nasal wash/aspirate specimens using the
Xpert Xpress SARSCoV-2 test run on the
GeneXpert Dx and GeneXpert Infinity systems
is limited to laboratories certified under the
Clinical Laboratory Improvement Amendments
of 1988 (CLIA), 42 U.S.C. § 263a, to perform
high and moderate complexity tests. Testing of
nasopharyngeal, nasal, or midturbinate swab
specimens using the Xpert Xpress SARS-CoV-
2 test run on the GeneXpert Xpress System
(Tablet and Hub Configurations) is limited to
laboratories certified under CLIA that meet
requirements to perform high, moderate, or
waived complexity tests. Testing of these
specimens is authorized for use at the Point of
Care (POC), i.e., in patient care settings
operating under a CLIA Certificate of Waiver,
Certificate of Compliance, or Certificate of
Accreditation. Results are for the detection of
SARS-CoV-2 RNA. The SARS-CoV-2 RNA is
generally detectable in upper respiratory
specimens during the acute phase of infection.
Positive results are indicative of active infection
with SARS-CoV2; clinical correlation with
patient history and other diagnostic information
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
is necessary to determine patient infection
status. Positive results do not rule out bacterial
infection or co-infection with other viruses. The
agent detected may not be the definite cause of
disease. Laboratories within the United States
and its territories are required to report all
positive results to the appropriate public health
authorities. Negative results do not preclude
SARS-CoV-2 infection and should not be used
as the sole basis for treatment or other patient
management decisions. Negative results must
be combined with clinical observations, patient
history, and epidemiological information.
Testing with the Xpert Xpress SARS-CoV-2 test
is intended for use by trained operators who are
proficient in performing tests using either
GeneXpert Dx, GeneXpert Infinity and/or
GeneXpert Xpress systems. The Xpert Xpress
SARS-CoV-2 test is only for use under the
Food and Drug Administration’s Emergency
Use Authorization.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1045 IMP/IVD/2020/000491 ASPEN De-proteinizer-Intended to maintain electrodes CDSCO Class B

DIAGNOSTICS PVT. on electrolyte analyzers ,Conditioning Solution-
LTD. Intended to maintain electrodes of electrolyte
analyzers ,Refill Solution (ISE)-Intended to
provide proper functioning of Electrodes used
for estimation of Sodium, Potassium, Chloride,
Calcium ph & Lithium parameters in
serum/plasma/ other body fluids.,Calibration
Standard Solution (ISE)-Reagent kit intended
for the estimation of Sodium, Potassium,
Chloride, Calcium ph & Lithium parameters in
serum/plasma/ other body fluids,Electrolytes
Quality Control (ISE)-Intended for Quality
control of reagent kits intended for estimation of
Sodium, Potassium, Chloride, Calcium ph &
Lithium parameters in serum/plasma/ other
body fluids.

1046 IMP/IVD/2020/000493 Holly Drugs Pvt. Ltd. COVID-19(SARS-CoV-2) Nucleic Acid Test Kit CDSCO Class C
(PCR-Fluorescence probe method)(SARS-CoV-
2 Nucleic Acid Test Kit)-The kit is used for the in
vitro detection of suspected cases and
suspected clustered cases of 2019-nCoV, as
well as 2019-nCoV nucleic acid in
oropharyngeal swabs, nasopharyngeal swabs
or sputum specimens of other patients who
need to go through infection diagnosis or
differential diagnosis of 2019-nCoV, and it is for
the auxiliary diagnosis of 2019-nCoV.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1047 IMP/IVD/2020/000495 CliniExperts Services Complete Whole Blood Collection CDSCO Class A
Pvt. Ltd Kit(Edinburgh Genetics)-Edinburgh Genetics
Complete Whole Blood Collection Kit is a
single-use device intended to be used by
healthcare professionals and researchers to
collect fingerprick whole blood samples.

1048 IMP/IVD/2020/000495 CliniExperts Services COVID-19 Colloidal Gold Immunoassay Testing CDSCO Class C
Pvt. Ltd Kit, IgG/IgM Combined(Edinburgh Genetics)-
This kit is used to qualitatively detect IgG and
IgM antibodies of the COVID-19 novel
coronavirus in human serum, plasma or whole
blood in vitro.

1049 IMP/IVD/2020/000496 Godolo & Godolo Diagnovital Sars-CoV-2 Real Time PCR CDSCO Class C
Exports Pvt Ltd . Kit(Diagnovital)-The use of real-time RT-PCR
assays is for the in vitro qualitative detection of
2019-Novel Coronavirus (SARS-CoV-2) in
respiratory specimens. The SARS-CoV-2
primer and probe sets are designed for the
specific detection of SARS-CoV-2.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1050 IMP/IVD/2020/000498 Abbott Healthcare Pvt. Alinity h-series Wright-Giemsa Stain(Alinity h- CDSCO Class B
Ltd. series Wright-Giemsa Stain)-The major function
of the Alinity h-series Wright-Giemsa Stain
solutions is to provide a Romanowsky dye (a
variety of thiazines and eosins) that is required
to stain blood films. These dyes impart
coloration to cells and other blood elements to
enable the differential identification of cells and
quality assessment of their morphology for
diagnostic purposes. The Alinity hs Slide Maker
Stainer Module supports the Alinity h-series
Wright-Giemsa Stain.,Alinity h-series May-
Grunwald-Giemsa Stain(Alinity h-series May-
Grunwald-Giemsa Stain)-The major function of
the stain solutions is to provide Romanowsky
dyes (a variety of thiazines and eosins) that are
required to stain blood films. These dyes impart
coloration to cells and other blood elements to
enable the differential identification of cells and
quality assessment of their morphology for
diagnostic purposes.,Alinity h-series Smear
Fix(Alinity h-series Smear Fix)-The smear fix
reagent is used for the following functions Fixes
and provides permeability of the cells in
preparation for staining. Preserves the
morphology of the cells.

1051 IMP/IVD/2020/000501 BIOHOUSE STAT-NAT COVID-19 B(STAT-NAT COVID-19 CDSCO Class C

SOLUTIONS PRIVATE B)-The STAT-NAT COVID-19 B kit is a
LIMITED lyophilized Real-time RT-PCR qualitative assay
based on nucleic acid amplification for the
identification of the novel Coronavirus SARS-
CoV-2 RNA in human respiratory tract
specimens. This assay is an aid in the
diagnosis of SARS-CoV-2 infection.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1052 IMP/IVD/2020/000502 Beckman Coulter India Axis Shield Liquid Stable (LS) 2-Part CDSCO Class B
Private Limited Homocysteine Reagent(Axis Shield Liquid
Stable (LS) 2-Part Homocysteine Reagent)-The
Liquid Stable (LS) 2-Part Homocysteine
Reagent is intended for in vitro quantitative
determination of total homocysteine in human
serum and plasma. The device can assist in the
diagnosis and treatment of patients suspected
of having hyperhomocysteinemia and
homocystinuria. ,Axis Shield Homocysteine
Controls (Axis Shield Homocysteine Controls )-
The Axis Shield Homocysteine Control Kit is
intended to be used as an assayed quality
control serum when used for the quantitative
measurement of total L-homocysteine in human
serum or plasma.

1053 IMP/IVD/2020/000509 CYGEN PHARMA & Allplex® 2019-nCov Assay (Allplex®)-AllplexTM CDSCO Class C
SURGICALS (A UNIT 2019-nCoV Assay is in vitro diagnostic medical
OF CYGEN device designed for qualitative detection of
CONSULTANCY PVT novel Corona virus (2019-nCoV) with real-time
LTD) reverse transcription PCR from sputum,
nasopharyngeal aspirate, throat &
nasopharyngeal swab, and bronchoalveolar
lavage.

1054 IMP/IVD/2020/000510 DEEP MEDITECH Anti-SARS-CoV-2 Rapid Test-For the rapid, CDSCO Class C
PVT. LTD. qualitative determination of Anti-SARS-CoV-2
(IgG/IgM antibodies of Severe Acute
Respiratory Syndrome Coronavirus 2) in human
serum, plasma or whole blood.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1055 IMP/IVD/2020/000511 Stag Global Private COVID-19 Test Kit-Genefinder COVID-19 Plus CDSCO Class C
Limited RealAmp Kit is the One-Step Reverse
Transcription Real-Time PCR Kit designed to
detect Novel Corona virus (COVID-19)
qualitatively through Reverse Transcription
reaction and Real-time Polymerase Chain
Reaction.

1056 IMP/IVD/2020/000512 Jaya Surgical And Novel Coronavirus(2019-nCoV) Nucleic Acid CDSCO Class C
Pharma Private Limited Diagnostic Kit-Novel Coronavirus(2019-nCoV)
Nucleic Acid Diagnostic Kit (PCR-Fluorescence
Probing) is used for qualitative detection of the
ORF1ab and N genes of novel coronavirus
(2019- nCoV) in nasopharyngeal swab,
oropharyngeal swab, alveolar lavage fluid,
sputum, serum, whole blood and feces from
suspected pneumonia cases with novel
coronavirus infection, patients with suspected
clusters of novel coronavirus infection, and
other patients requiring diagnosis or differential
diagnosis of novel coronavirus infection

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1057 IMP/IVD/2020/000513 BHARAT RADI PREP Swab and Stool DNA/RNA CDSCO Class C
PARENTERALS LTD. KIT(RADI PREP Swab and Stool DNA/RNA
KIT)-The RADI PREP Swab and Stool DNA /
RNA KIT is a reagent used to extract nucleic
acids from bacteria and viruses present in
samples collected from human feces, anus,
vagina, or pharynx using cotton swabs. The
extracted nucleic acid can be used in all
experiments that require nucleic acids, such as
real-time PCR and NGS. The kit is for use by a
laboratory professional.,RADI COVID-19
Detection Kit(RADI COVID-19 Detection Kit)-
The RADI COVID-19 Detection Kit is an in vitro
diagnostic medical device, based on real time
RT-PCR technology utilizing reverse-
transcriptase (RT) reaction to convert RNA into
complementary DNA (cDNA). It is intended for
the presumptive qualitative detection of nucleic
acid from the COVID-19 in upper and lower
respiratory specimens.

1058 IMP/IVD/2020/000514 Invitrogen Bioservices TaqPath™ COVID-19 CE-IVD RT-PCR CDSCO Class C
India Pvt. Ltd. Kit(Applied Biosystems)-TaqPath™ COVID-19
CE-IVD RT-PCR Kit contains the reagents and
controls for a real-time reverse transcription
polymerase chain reaction (RT-PCR) test
intended for the qualitative detection of nucleic
acid from SARS-CoV-2 in nasopharyngeal
swab, nasopharyngeal aspirate, and
bronchoalveolar lavage (BAL) specimens from
individuals suspected of COVID-19.Update in
Instruction for Use is acknowledged.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1059 IMP/IVD/2020/000518 Abbott Healthcare Pvt. Alinity h-series AutoClean Solution(Alinity h- CDSCO Class B
Ltd. series AutoClean Solution)-Alinity h-series
AutoClean Solution is intended to clean and
sanitize the Alinity hq module.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1060 IMP/IVD/2020/000523 Anand Brothers Premier Wash Reagent(Premier Wash CDSCO Class B
Reagent)-The Premier Diluent reagent is
intended for use with Trinity Biotech Premier
Hb9210TM HbAIC Analyzer only. The premier
system is intended for the quantitative
measurement of hemoglobin A1c (HbA1C) in
human capillary and venous whole blood.
HbA1C is used for the monitoring of long-term
glycemic control in individuals with diabets
mellitus.,Premier Buffer A Reagent(Premier
Buffer A Reagent)-This reagent is intended for
use with Trinity Biotech Premier Hb9210TM
HbAIC Analyzer only. The premier Hb9210TM
system is intended for the quantitative
measurement of hemoglobin A1c (HbA1C) in
human capillary and venous whole blood.
HbA1C is used for the monitoring of long term
glycemic control in individuals with diabets
mellitus.,Premier Buffer B Reagent(Premier
Buffer B Reagent)-This reagent is intended for
use with Trinity Biotech Premier Hb9210TM
HbAIC Analyzer only. The premier Hb9210TM
system is intended for the quantitative
measurement of hemoglobin A1c (HbA1C) in
human capillary and venous whole blood.
HbA1C is used for the monitoring of long term
glycemic control in individuals with diabets
mellitus.,Premier Affinity A1c(Premier Affinity
A1c)-Premier Affinity AIc set is intended for use
with Trinity biotech Premier Hb9210TM
Analyzer only. The Premier Affinity AIc is
intended for the quantitative measuement of
hemoglobin AIc (HbA1c) in human capillary and
venous whole blood.,HbA1c (GHb) Control
kit(HbA1c (GHb) Control kit)-HbA1c (GHb)
controls are intended to monitor the
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
performance of glycated hemoglobin
assays.,Premier Diluent Reagent(Premier
Diluent Reagent)-The Premier Diluent reagent
is intended for use with Trinity Biotech Premier
Hb9210TM HbAIC Analyzer only. The premier
system is intended for the quantitative
measurement of hemoglobin A1c (HbA1C) in
human capillary and venous whole blood.
HbA1C is used for the monitoring of long-term
glycemic control in individuals with diabets
mellitus.,HbA1c (GHb) Calibrator Kit(HbA1c
(GHb) Calibrator Kit)-HbAIc (GHb) Calibrators
are intended to monitor the performance of
glycated hemoglobin assays. Calibrators are for
the calibration of quantitative HbAIc affinity
assay systems.

1061 IMP/IVD/2020/000524 Anand Brothers Acetylcholine Receptor-Ab (ARAb) CDSCO Class B

RRA(Acetylcholine Receptor-Ab (ARAb) RRA)-
Radio receptor assay for the in-vitro-diagnostic
semi-quantitative determination of
autoantibodies against the acetylcholine
receptor in human serum and pasma

1062 IMP/IVD/2020/000525 PerkinElmer India Pvt. chemagic Viral DNA/RNA 300 Kit CDSCO Class C
Ltd. H96(chemagic Viral DNA/RNA 300 Kit H96)-
The chemagic Viral DNA/RNA Kits are
designed for simultaneous purification of viral
DNA or RNA from Plasma, Serum, Naso or
Oropharyngeal Swabs, BAL and Sputum
samples

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1063 IMP/IVD/2020/000526 Imperial Life Sciences PCLMD nCoV one step RT-PCR Kit(PCL)-The CDSCO Class C
Pvt. Ltd. PCLMD nCoV one step RT-PCR Kit is a
qualitative real-time reverse transcription PCR
(RT-PCR) IVD medical device for the detection
of SARS-CoV-2 in human nasopharyngeal
specimen.

1064 IMP/IVD/2020/000527 Innvolution Healthcare Viral DNA/RNA Mini Kit(Viral DNA/RNA Mini CDSCO Class C
Pvt. Ltd., Kit)-For isolation of viral RNA/ viral nucleic acid
from cell-free fluid such as, serum, plasma,
body fluid and cell culture supernatant, and
from transport medium of swabs ,GB SARS-
CoV-2 Real-Time RT-PCR(GB SARS-CoV-2
Real-Time RT-PCR)-The GB SARS-CoV-2
Real-Time RT-PCR is an in vitro nucleic acid
amplification test (NAT) for the qualitative
detection of 2019 Novel Coronavirus (SARS-
CoV-2) in respiratory tract specimens (i.e.,
nasopharyngeal/ oropharyngeal swab or
sputum specimens), serum or plasma.,GB
SARS-CoV-2 Real-Time RT-PCR(GB SARS-
CoV-2 Real-Time RT-PCR)-The GB SARS-
CoV-2 Real-Time RT-PCR is an in vitro nucleic
acid amplification test (NAT) for the qualitative
detection of 2019 Novel Coronavirus (SARS-
CoV-2) in respiratory tract specimens (i.e.,
nasopharyngeal/ oropharyngeal swab or
sputum specimens), serum or plasma.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1065 IMP/IVD/2020/000528 Siemens Healthcare DIAGNOVITAL® SARS-Cov-2 Real time PCR CDSCO Class C
Private Limited kit(DIAGNOVITAL®SARS-Cov-2 Real time
PCR kit)-DIAGNOVITAL® SARS-CoV-2 Real-
Time PCR Kit is an in vitro nucleic acid
amplification assay for qualitative detection of
2019-Novel Coronavirus (SARS-CoV-2) in
respiratory specimens using RTA Viral Nucleic
Acid Isolation Kit and BIO-RAD CFX96-IVD or
Rotor-Gene 3000/6000 or Applied Biosystems
7500 or QuantStudio 5 Real-Time PCR
Detection Systems for amplification, detection
and analysis.

1066 IMP/IVD/2020/000531 Bilcare Limited Real-Q 2019-nCoV Detection Kit (Real-Q 2019- CDSCO Class C
nCoV Detection Kit )-It is an in vitro diagnostic
medical device that qualitatively detects the
gene (E gene, RdRp gene) of the coronavirus
disease (COVID-19) in samples (sputum,
oropharyngeal and nasopharyngeal specimens)
of patients with respiratory infections using real-
time polymerase chain reaction

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1067 IMP/IVD/2020/000532 MATRIX Diluent for Mythic 22(Diluent for Mythic 22)- CDSCO Class B
HEALTHCARE PVT. Isotonic solution use for the differentiation of
LTD. the white blood cells,Mythic 18-22 Enzymatic
Cleaning Solution(Mythic 18-22 Enzymatic
Cleaning Solution)-This solution is used to
clean the system.The presence of an enzyme
reduces the formation of Proteins
deposit,OnlyOne(OnlyOne)-Lysing agent to
obtain the measurement of the
haemoglobin,counting and differentiation of the
white blood cells.,Mythic 18 Diluent(Mythic 18
Diluent)-Isotonic solution use for the
differentiation of the white blood cells.,Mythic
18 Cyanide free Lytic solution(Mythic 18
Cyanide free Lytic solution)-Lysing agent to
obtain the measurement of the
haemoglobin,counting and differentiation of the
white blood cells.,Mythic 18-22 FLUSH
CLEANER(Mythic 18-22 FLUSH CLEANER)-
Mythic 18-22 FLUSH CLEANER is an
emergency cleaner ,based on hypochlorite,
designed for washing and maintenance of
Mythic haematology analysers.,Cleaner for
Mythic 22(Cleaner for Mythic 22)-This solution
is used to clean the system.The presence of an
enzyme reduces the formation of Proteins
deposit.,Myt-CAL(Myt-CAL)-Myt-CAL is
designed for use in the calibration of Orphee
haematology analyzers.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1068 IMP/IVD/2020/000534 MCW Healthcare Pvt. nCOVID-19 IgG&IgM POCT(nCOVID-19 CDSCO Class C
Ltd. IgG&IgM POCT)-The nCOVID-19 IgG&IgM
POCT kit adopts the solid phase colloidal gold
immunochromatographic technology for the
qualitative determination of IgM/IgG antibodies
against SARS-CoV-2 in human serum, plasma,
and whole blood. This assay is used as a
diagnostic aid when assessing immunity status
of patients related to COVID-19 infection. This
product must be used in strict compliance with
the instructions given in this document by
professional users

1069 IMP/IVD/2020/000536 PerkinElmer India Pvt. PerkinElmer® New Coronavirus Nucleic Acid CDSCO Class C
Ltd. Detection Kit(PerkinElmer® New Coronavirus
Nucleic Acid Detection Kit)-As per Emergency
Use Authorization (EUA) from USFDA, This test
is also for the qualitative detection of nucleic
acid from the SARS-CoV-2 virus in pooled
samples containing up to 5 individual upper
respiratory swab specimens(oropharyngeal,
nasopharyngeal,or anterior nasal swabs),
where each specimen is collected under
observation or by a healthcare provider using
individual vials containing transport media.

1070 IMP/IVD/2020/000538 BRINTON Real-time fluorescent RT-PCR Kit for detecting CDSCO Class C
PHARMACEUTICALS 2019-nCoV(BGI)-The kit is qualitative in vitro
LTD. nucleic acid amplification assay to detect the
new coronavirus identified in china in 2019
using reverse transcription PCR in specimen of
the throat swab and Bronchoalveolar lavage
fluid (BALF).

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1071 IMP/IVD/2020/000539 CliniExperts Services RealCycler CORO-G v.5.3(RealCycler)- CDSCO Class C

Pvt. Ltd RealCycler CORO-G v.5.3 is an in vitro
diagnostic kit of reagents which allows the
detection of Coronavirus SARS-CoV-2 and
SarbecovirusRNA in clinical samples.

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No.  License Number  Name  Use  Authority  Class 

1072 IMP/IVD/2020/000548 M/s. Ortho Clinical VITROS Immunodiagnostic Products Anti- CDSCO Class C
Diagnostics India SARS-CoV-2 Total Reagent Pack-For in vitro
Private Limited diagnostic and Laboratory Professional use.
The VITROS Immunodiagnostic Products Anti-
SARS-CoV-2 Total Reagent Pack test when
used in combination with the VITROS
Immunodiagnostic Products Anti-SARS-CoV-2
Total Calibrator is for the qualitative
measurement of total antibody (including IgG,
IgA and IgM) to SARS-CoV-2 in human serum
and plasma (K2 EDTA) samples from patients
suspected of COVID-19 by a healthcare
provider, using VITROS Immunodiagnostic and
Integrated Systems.,VITROS
Immunodiagnostic Products Anti‑SARS-CoV-2
Total Controls-For in vitro diagnostic and
Laboratory Professional use. For use in
monitoring the performance of the VITROS
Immunodiagnostic and Integrated Systems
when used for the determination of antibodies
to SARS-CoV-2.,VITROS Immunodiagnostic
Products Anti-SARS-CoV-2 IgG Calibrator-For
in vitro diagnostic and Laboratory Professional
use. The VITROS Immunodiagnostic Products
Anti-SARS-CoV-2 IgG Reagent Pack when
used in combination with the VITROS
Immunodiagnostic Products Anti-SARS-CoV-2
IgG Calibrator is a chemiluminescent
immunoassay test intended for the qualitative
detection of IgG antibodies to SARS-CoV-2 in
human serum using VITROS Immunodiagnostic
and Integrated Systems.,VITROS
Immunodiagnostic Products Anti-SARS-CoV-2
Total Calibrator-For in vitro diagnostic and
Laboratory Professional use. The VITROS
Immunodiagnostic Products Anti-SARS-CoV-2
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Total Reagent Pack test when used in
combination with the VITROS
Immunodiagnostic Products Anti-SARS-CoV-2
Total Calibrator is for the qualitative
measurement of total antibody (including IgG,
IgA and IgM) to SARS-CoV-2 in human serum
and plasma (K2 EDTA) samples from patients
suspected of COVID-19 by a healthcare
provider, using VITROS Immunodiagnostic and
Integrated Systems.,VITROS
Immunodiagnostic Products Anti-SARS-CoV-2
IgG Reagent Pack-For in vitro diagnostic and
Laboratory Professional use. The VITROS
Immunodiagnostic Products Anti-SARS-CoV-2
IgG Reagent Pack when used in combination
with the VITROS Immunodiagnostic Products
Anti-SARS-CoV-2 IgG Calibrator is a
chemiluminescent immunoassay test intended
for the qualitative detection of IgG antibodies to
SARS-CoV-2 in human serum using VITROS
Immunodiagnostic and Integrated Systems

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1073 IMP/IVD/2020/000549 LOFTEN INDIA PVT COVID-19 Real-time RT-PCR Kit(LiliF)-LiliF™ CDSCO Class C
LTD COVID-19 Real-time RT-PCR Kit is in vitro
diagnostic medical device based on real-time
reverse transcription PCR method intended for
the qualitative detection of nucleic acid from the
2019-nCoV in nasopharyngeal/oropharyngeal
swabs and sputa from individuals with signs
and symptoms of infection who are suspected
of COVID-19,COVID-19 Multi Real-time RT-
PCR Kit(LiliF)-LiliF™ COVID-19 Multi Real-time
RT-PCR Kit is in vitro diagnostic medical device
based on real-time reverse transcription PCR
method intended for the qualitative detection of
nucleic acid from the 2019-nCoV in
nasopharyngeal/oropharyngeal swabs and
sputa from individuals with signs and symptoms
of infection who are suspected of COVID-19

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No.  License Number  Name  Use  Authority  Class 

1074 IMP/IVD/2020/000550 Kin Diagnostics Covid-19 Real Time PCR Kit(PowerChek™ CDSCO Class C
SARS-CoV-2 Real-time PCR Kit )-"The
PowerChek™ SARS-CoV-2 Real-time PCR Kit
is a real-time RT-PCR test intended for the
qualitative detection of nucleic acid from the
SARS-CoV-2 that causes Coronavirus Disease
2019 (COVID-19) in clinical specimens,
including upper and lower respiratory
specimens (such as nasopharyngeal/
oropharyngeal swabs, bronchoalveolar lavage
fluid, and sputum) obtained from individuals
with signs and symptoms of infection who are
suspected of COVID-19 by their healthcare
provider. Results are for the identification of
SARS-CoV-2 RNA. The SARS-CoV-2 RNA is
generally detectable in upper and lower
respiratory specimens during infection. Positive
results are indicative of the presence of SARS-
CoV-2 RNA, clinical correlation with patient
history and other diagnostic information is
necessary to determine patient infection
status."

1075 IMP/IVD/2020/000551 Gravity Global Covid-19 qPCR Multi Testing Kit(1copy CDSCO Class C
Hospitality Private TM)-1copy™ COVID-19 qPCR Kit is an In-Vitro
Limited Diagnostic medical device for qualitative
analysis of E gene and RdRp gene for
coronavirus (COVID-19) in extracted RNA from
sputum, nasopharyngeal swab and
oropharyngeal swab of patients with suspected
respiratory infections.

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No.  License Number  Name  Use  Authority  Class 

1076 IMP/IVD/2020/000554 Tosoh India Pvt Ltd SARS-CoV-2 (COVID-19) IgA (NovaLisa®)-The CDSCO Class C
SARS-CoV-2 (COVID-19) IgA ELISA is
intended for the qualitative determination of IgA
class antibodies against SARS‑CoV‑2 in human
serum or plasma (citrate, heparin) to support
the diagnosis of COVID-19 disease and
constitutes a supplement to direct pathogen
detection.,SARS-CoV-2 (COVID-19)
IgG(NovaLisa®)-The SARS-CoV-2 (COVID-19)
IgG ELISA is intended for the qualitative
determination of IgG class antibodies against
SARS CoV-2 in human serum or plasma
(citrate, heparin) to support the diagnosis of
COVID-19 disease and constitutes a
supplement to direct pathogen detection. In
addition, serology can be used to collect
epidemiological information on the prevalence
of SARS CoV-2.,SARS-CoV-2 (COVID-19)
IgM(NovaLisa®)-The SARS-CoV-2 (COVID-19)
IgM ELISA is intended for the qualitative
determination of IgM class antibodies against
SARS‑CoV‑2 in human serum or plasma
(citrate, heparin) to support the diagnosis of
COVID-19 disease and constitutes a
supplement to direct pathogen detection.

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No.  License Number  Name  Use  Authority  Class 

1077 IMP/IVD/2020/000555 MERIDIAN BIOTECH Allplex™ 2019- nCov Assay(Allplex™)- CDSCO Class C
Allplex™ 2019-nCoV Assay is in vitro
diagnostic medical device designed for
qualitative detection of novel Corona virus
(2019-nCoV) with real-time reverse
transcription PCR from sputum,
nasopharyngeal aspirate, throat &
nasopharyngeal swab, and bronchoalveolar
lavage.,Allplex™ 2019-nCoV Assay(Allplex™)-
Allplex™ 2019-nCoV Assay is an in vitro
diagnostic (IVD) real-time RT-PCR test
intended for the qualitative detection of SARS-
CoV-2 viral nucleic acids in human
nasopharyngeal swab, oropharyngeal swab,
anterior nasal swab, mid-turbinate nasal swab,
nasopharyngeal wash/aspirate, nasal aspirate,
bronchoalveolar lavage (BAL) and sputum
specimens from individuals who are suspected
of COVID-19 by their health care
provider.,Allplex™ SARS-CoV-2 Master
Assay(Allplex™)-Allplex™ SARS-CoV-2 Master
Assay is in vitro diagnostic medical device
designed for qualitative detection of SARS-
CoV-2 and variants of S gene (HV69/70del,
Y144del, E484K, N501Y, P681H) with real-time
reverse transcription PCR from nasopharyngeal
aspirate, nasopharyngeal swab,
bronchoalveolar lavage, oropharyngeal (throat)
swab, sputum, and saliva.,Allplex™ SARS-
CoV-2/FluA/FluB/RSV Assay(Allplex™)-
Multiplex real-time one-step RT-PCR system for
detection of SARS-CoV-2, Influenza A virus,
Influenza B virus, and Human respiratory
syncytial virus from nasopharyngeal aspirate,
nasopharyngeal swab, bronchoalveolar lavage,
and saliva. The detection of SARS-CoV-2 is
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No.  License Number  Name  Use  Authority  Class 
additionally validated on oropharyngeal (throat)
swab and sputum.

1078 IMP/IVD/2020/000564 TULIP DIAGNOSTICS PerkinElmer® New Coronavirus Nucleic Acid CDSCO Class C
PRIVATE LIMITED Detection Kit(PerkinElmer® New Coronavirus
Nucleic Acid Detection Kit)-The PerkinElmer®
New Coronavirus Nucleic Acid Detection Kit is a
real-time RTPCR in vitro diagnostic test
intended for the qualitative detection of nucleic
acid from the SARSCoV- 2 virus in human
oropharyngeal swab and nasopharyngeal swab
specimens collected from individuals suspected
of COVID-19 by their healthcare provider.

1079 IMP/IVD/2020/000565 NovoMed Incorporation GA CoV-2 IgG-Enzyme Immunoassay for the CDSCO Class B
Pvt. Ltd. determination of IgG antibodies to SARS-
Coronavirus 2 (SARS-CoV-2) in human serum
and plasma for the monitoring of immune
response in COVID-19 disease.

1080 IMP/IVD/2020/000565 NovoMed Incorporation GA CoV-2 IgM-Enzyme Immunoassay for the CDSCO Class C
Pvt. Ltd. determination of IgM antibodies to SARS-CoV-2
in human serum and plasma for the monitoring
of immune response in COVID-19 disease. ,GA
CoV-2 IgG +-Enzyme Immunoassay for the
confirmation of positive IgG antibodies against
SARS-CoV-2 in human serum and plasma for
the monitoring of immune response in COVID-
19 disease.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1081 IMP/IVD/2020/000568 Grifols India Healthcare Procleix Ultrio Elite Assay Kit (A qualitative In- CDSCO Class D
Private Limited Vitro nucleic acid amplification test for the
detection of HIV 1 & 2 RNA, HCV RNA and
HBV DNA in plasma and serum specimens
from human donors)(Procleix Ultrio Elite)-The
Procleix Ultrio Elite Assay is a qualitative in vitro
nucleic acid amplification test for the detection
of human immunodeficiency virus type 1 and
human immunodeficiency virus type 2 (HIV)
RNA, hepatitis C virus (HCV) RNA, and/or
hepatitis B virus (HBV) DNA in plasma and
serum specimens from human donors, tested
individually or in pools. It is also intended for
use in testing plasma and serum to screen
organ and tissue donors, including cadaveric
(nonheart- beating) donors.,Procleix Ultrio Plus
Assay Kit (A qualitative In-Vitro nucleic acid
amplification test for the detection of HIV 1
RNA, HCV RNA and HBV DNA in plasma and
serum specimens from human donors)(Procleix
Ultrio Plus)-The Procleix Ultrio Plus Assay is a
qualitative in vitro nucleic acid amplification test
for the detection of human immunodeficiency
virus type 1 (HIV-1) RNA, hepatitis C virus
(HCV) RNA, and/or hepatitis B virus (HBV)
DNA in plasma and serum specimens from
human donors, tested individually or in pools. It
is also intended for use in testing plasma and
serum to screen organ and tissue donors,
including cadaveric (non-heart-beating) donors

1082 IMP/IVD/2020/000570 M/S VANMAUR Sample Preservation Solution (Viral Transport CDSCO Class B
ENTERPRISE Medium)(Longsee)-Sample preservation
PRIVATE LIMITED

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1083 IMP/IVD/2020/000570 M/S VANMAUR RNA Extraction Kit(Longsee)-Rapid Extraction CDSCO Class C
ENTERPRISE of High Purity Viral Nucleic Acid RNA
PRIVATE LIMITED

1084 IMP/IVD/2020/000571 M/s.Roche Diabetes Blood Glucose test Strips(ACCU CHEK CDSCO Class B
Care India Private Instant)-The Accu‑Chek Instant test strips with
Limited the Accu‑Chek Instant and Accu-Chek Instant S
meters are intended to quantitatively measure
glucose in fresh capillary whole blood from the
finger, palm, forearm, and upper arm as an aid
in monitoring the effectiveness of glucose
control. The Accu‑Chek Instant test strips with
the Accu‑Chek Instant and Accu-Chek Instant S
meters are intended for in vitro diagnostic self-
testing by people with diabetes. The Accu‑Chek
Instant test strips with the Accu‑Chek Instant
and Accu-Chek Instant S meters are intended
for in vitro diagnostic use by healthcare
professionals in clinical settings. Venous,
arterial, and neonatal blood testing is limited to
healthcare professional use. This system is not
for use in diagnosis of diabetes mellitus, nor for
testing neonate cord blood samples.

1085 IMP/IVD/2020/000574 Allied Biotechnology Transport Medium(Biocomma Transport and CDSCO Class A
India Pvt. Ltd. preservation Medium)-Intended for the
collection storage and transport ofviruses,
mycoplasma, chlamydiae or ureaplasma
specimens from the collection site to the testing
laboratory.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1086 IMP/IVD/2020/000574 Allied Biotechnology Nucleic Acid Extraction or purification CDSCO Class C
India Pvt. Ltd. Reagent(commaXP virus DNA/RNA
Extraction)-Intended for dNA/RNA extractions
from blood tissue organs enviornmental sample
saliva nasal liquid and swab sample

1087 IMP/IVD/2020/000576 M/s.Roche Diabetes Blood Glucose test Strips(ACCU CHEK CDSCO Class B
Care India Private Instant)-The Accu Chek Instant test strips with
Limited the Accu Chek Instant and Accu-Chek Instant S
meters are intended to quantitatively measure
glucose in fresh capillary whole blood from the
finger, palm, forearm, and upper arm as an aid
in monitoring the effectiveness of glucose
control. The Accu Chek Instant test strips with
the Accu Chek Instant and Accu-Chek Instant S
meters are intended for in vitro diagnostic self-
testing by people with diabetes. The Accu Chek
Instant test strips with the Accu Chek Instant
and Accu-Chek Instant S meters are intended
for in vitro diagnostic use by healthcare
professionals in clinical settings. Venous,
arterial, and neonatal blood testing is limited to
healthcare professional use. This system is not
for use in diagnosis of diabetes mellitus, nor for
testing neonate cord blood samples.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1088 IMP/IVD/2020/000578 SOWAR PRIVATE OPTI CCA-TS2 Blood Gas & Electrolyte CDSCO Class A
LIMITED Analyzer(GD7046 OPTI Critical care Analyzer
with Accessory Kit (OPTI CCA-TS2))-The OPTI
CCA-TS2 system is a portable [4.7 x 14.2 x 9.1
inches, 12 pounds], microprocessor based
instrument using optical fluorescence for the
measurement of blood gases, electrolytes and
enzymes and utilizes a graphical touch screen
interface. There is an additional laser-based
measurement of total hemoglobin (tHb) and
502 capability available with any cassette that
contains a p02 sensor. Measurements require
the use of a disposable cassette to bring
samples into contact with sensors designed to
fluoresce in relationship with the quantity of the
analytes contained in the sample for every
analyte except tHb and 502. Lasers on board
the CCA-TS2 analyzer measure tHb and 502 in
blood samples contained in the cassette using
reflectance principles.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1089 IMP/IVD/2020/000578 SOWAR PRIVATE OPTI CHECK LEVEL 3(OPTI Medical)-Liquid CDSCO Class B
LIMITED quality control vials used to check the accuracy
of the OPTI CCA Analyzer's PCO2 & PO2, Na,
K, Cl & Ca sensors,OPTI CHECK PLUS LEVEL
2(OPTI Medical)-Liquid quality control vials
used to check the accuracy of the OPTI CCA
Analyzers PCO2 & PO2, Na, K, Cl, Ca, & Glu,
sensors,OPTI CHECK PLUS LEVEL 3(OPTI
Medical)-Liquid quality control vials used to
check the accuracy of the OPTI CCA Analyzers
PCO2 & PO2, Na, K, Cl, Ca, & Glu,
sensors,OPTI Check Lytes Level 1(OPTI
Medical)-Liquid quality control vials used to
check the accuracy of the OPTI LION
instruments Na, K, Cl, Ca & pH sensors,OPTI
Check Lytes Level 2(OPTI Medical)-Liquid
quality control vials used to check the accuracy
of the OPTI LION instruments Na, K, Cl, Ca &
pH sensors,OPTI Check Lytes Level 3(OPTI
Medical)-Liquid quality control vials used to
check the accuracy of the OPTI LION
instruments Na, K, Cl, Ca & pH sensors,E-Ca
Cassettes(OPTI Medical)-Cassette is used with
the OPTI CCA ANALYZER to detect pH, PCO2,
PO2, Ca, Na, K, tHB & SO2 in whole blood,
serum or plasma.,B-Type Cassettes(OPTI
Medical)-Cassette is used with the OPTI CCA
ANALYZER to detect pH, PCO2, PO2, tHB &
SO2 in whole blood, serum or plasma.,E-Cl
Cassettes(OPTI Medical)-Cassette is used with
the OPTI CCA ANALYZER to detect pH, PCO2,
PO2, Cl, Na, K, tHB & SO2 in whole blood,
serum or plasma.,B Lac Cassettes(OPTI
Medical)-Cassette is used with the OPTI CCA
ANALYZER WITH TOUCH SCREEN to detect
pH, PCO2, PO2, & Lactate in whole blood,
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
serum or plasma.,E Plus Cassettes(OPTI
Medical)-Cassette is used with the OPTI LION
ANALYZER to detect Na, K, Cl, Ca & pH in
whole blood, serum or plasma.,E-Glu
Cassettes(OPTI Medical)-Cassette is used with
the OPTI CCA ANALYZER to detect pH, PCO2,
PO¬2, Glu, Na, K, tHB & SO2 in whole blood.
serum or plasma.,E-Bun Cassettes(OPTI
Medical)-Cassette is used with the OPTI CCA
ANALYZER W|TH TOUCH SCREEN to detect
pH, PCO2, PO2, BUN/UREA, Na, K, tHb, SO2
in whole blood, serum or plasma.,B-60
Cassettes(OPTI Medical)-Cassette is used with
the OPTI CCA ANALYZER to detect pH, PCO2
& PO2 in whole blood, serum or plasma.,E
Cassettes(OPTI Medical)-Cassette is used with
the OPTI CCA ANALYZER to detect pH, pH,
PCO2, PO2, tHb, SO2,OPTI CHECK LEVEL
1(OPTI Medical)-Liquid quality control vials
used to check the accuracy of the OPTI CCA
Analyzer's PCO2 & PO2, Na, K, Cl & Ca
sensors,OPTI CHECK LEVEL 2(OPTI Medical)-
Liquid quality control vials used to check the
accuracy of the OPTI CCA Analyzer's PCO2 &
PO2, Na, K, Cl & Ca sensors,OPTI CHECK
PLUS LEVEL 1(OPTI Medical)-Liquid quality
control vials used to check the accuracy of the
OPTI CCA Analyzer's PCO2 & Class B PO2,
Na, K, Cl, Ca & Glu sensors

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1090 IMP/IVD/2020/000580 Artec Diagnostic U-TOP COVID-19 Detection Kit for SARS- CDSCO Class C
System COV2 (Covid-19) Real Time PCR Kit(U-TOP)-
The U-TOP COVID-19 Detection Kit is a one-
step real-time RT-PCR test intended for the
qualitative detection of nucleic acid from SARS-
CoV-2 in oropharyngeal and nasopharyngeal
swab specimens, anterior nasal and mid-
turbinate nasal swabs, nasopharyngeal
wash/aspirate or nasal aspirate specimens and
sputum from individuals who are suspected of
COVID-19 by their healthcare provider. Testing
is limited to laboratories certified under the
Clinical Laboratory Improvement Amendments
of 1988 (CLIA), 42 U.S.C. §263a, to perform
high complexity tests.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1091 IMP/IVD/2020/000581 M/s Hemogenomics Human papillomavirus (HPV) Assay. (A target CDSCO Class C
Private Limited amplification nucleic acid probe test for the in
vitro qualitative detection of E6/E7 viral
messenger RNA of human papillomavirus )
(Aptima HPV Assay)-The Aptima HPV assay is
an in vitro nucleic amplification test for the
qualitative detection of E6/E7 viral messenger
RNA (mRNA) from 14 high-risk types of human
papillomavirus (HPV) in cervical specimens.
The high-risk HPV types detected by the assay
include: 16,18,
31,33,35,39,45,51,52,56,58,59,66 and
68.,Human papillomavirus 16, 18/45 Genotype
Assay (A target amplification nucleic acid probe
test for the in vitro qualitative detection of E6/E7
viral messenger RNA from high-risk types
16,18/45 of HPV)(Aptima HPV 16, 18/45
Genotype Assay)-The Aptima HPV 16, 18/45
genotype assay is an in vitro nucleic acid
amplification test for the qualitative detection of
E6/E7 viral messenger RNA (mRNA) from
human papillomavirus (HPV) high-risk types 16,
18 and 45 in samples from woman with positive
Aptima HPV assay results. HPV mRNA is
detected in liquid-based cytology cervical Pap
specimens.,SARS-CoV-2 RT PCR assay (A
nucleic acid amplification in vitro diagnostic test
intended for the qualitative detection of RNA
from SARS-CoV-2)(Aptima™ SARS-CoV-2
Assay)-The Aptima™ SARS-CoV-2 assay is a
nucleic acid amplification in vitro diagnostic test
intended for the qualitative detection of RNA
from SARS-CoV-2 isolated and purified from
nasopharyngeal (NP), nasal, mid-turbinate and
oropharyngeal (OP) swab specimens,
nasopharyngeal wash/ aspirate or nasal
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
aspirates obtained from individuals meeting
COVID-19 clinical and/or epidemiological
criteria.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1092 IMP/IVD/2020/000585 Randox Laboratories -GT (GGT)-A -GT (GGT) test system is a CDSCO Class B
India Pvt Ltd device intended for the quantitative in vitro
determination of L- -Glutamyltranserase (--
GT) activity in serum and plasma. This product
is suitable for use on RE Series
instruments.,Serum Iron (Fe)-The Serum Iron
(Fe) is intended for the quantitative in vitro
determination of Iron concentration in serum
and plasma. This product is suitable for manual
use and on semi-automated
instruments.,Lactate Dehydrogenase (LDH) -A
lactate dehydrogenase test system is a device
intended for the quantitative in vitro
determination of Lactate Dehydrogenase
activity in serum and plasma.,Rheumatoid
Factor (RF)-The Rheumatoid Factor (RF) test
system is a device intended for the quantitative
in vitro determination of Rheumatoid Factors
(RF) concentration in serum. Suitable for use of
RX series instruments.,Immunoassay Premium
-The Immunoassay Premium device is intended
for in vitro diagnostic use, in the quality control
of diagnostic assays. The Immunoassay
Premium and Immunoassay Premium Plus is
for the control of accuracy. ,Lactate
Dehydrogenase (LDH) -A lactate
dehydrogenase test system is a device
intended for the quantitative in vitro
determination of Lactate Dehydrogenase
activity in serum and plasma.,LDL Cholesterol
(LDL) -The LDL Cholesterol (LDL) device is
intended for the quantitative in vitro
determination of LDL-Cholesterol concentration
in human serum and plasma. ,Liquid Assayed
Specific Protein Control (SP CONTROL) -The
Liquid Assayed Specific Protein Control (SP
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No.  License Number  Name  Use  Authority  Class 
CONTROL) is intended for in vitro diagnostic
use, in the quality control of serum on clinical
chemistry systems. The Assayed Liquid Protein
Controls are for the control of accuracy.
,Microalbumin (mALB) -The Microalbumin
(mALB) reagent device is intended for the
quantitative in vitro determination of
Microalbumin in urine.,Rheumatoid Factor (RF)
-The Rheumatoid Factor (RF) test system is a
device intended for the quantitative in vitro
determination of Rheumatoid Factors (RF)
concentration in serum. Suitable for use of RX
series instruments,Ammonia (NH3) -The
Ammonia (NH3) device is for the quantitative in
vitro determination of Ammonia in plasma.
,Total Protein (UP) -The Total Protein (UP) is
intended for the quantitative in vitro
determination of total protein in urine and C.S.F.
This product is suitable for manual use and on
semi-automated instruments.,Serum Iron (Fe) -
The Serum Iron (Fe) is intended for the
quantitative in vitro determination of Iron
concentration in serum and plasma. This
product is suitable for manual use and on semi-
automated instruments.,Haemoglobin A1c
Control Set (HbA1c Control) -The Haemoglobin
A1c Control Set (HbA1c Control) is intended for
in vitro diagnostic use, in the quality control of
HbA1c on clinical chemistry systems. ,Serum
Iron (Fe) -The Serum Iron (Fe) is intended for
the quantitative in vitro determination of Iron
concentration in serum and plasma. This
product is suitable for manual use and on semi-
automated instruments. ,Calcium (Ca)-The
Calcium (Ca) is intended for the quantitative in
vitro determination of Calcium in serum, plasma

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No.  License Number  Name  Use  Authority  Class 
and urine,Amylase (AMY) -The Amylase (AMY)
reagent device is required for the quantitative in
vitro determination of Amylase in serum,
plasma or urine,Amylase (AMY)-The Amylase
(AMY) reagent device is required for the
quantitative in vitro determination of Amylase in
serum, plasma or urine,Amylase (AMY)-The
Amylase (AMY) reagent device is required for
the quantitative in vitro determination of
Amylase in serum, plasma or urine,Uric Acid
(UA) -The Uric Acid (UA) is intended for the
quantitative in vitro determination of Uric Acid
concentration in serum, plasma and urine.
,Triglycerides (TRIGS) -The Triglycerides
(TRIGS) is intended for the quantitative in vitro
determination of triglyceride concentration in
serum and plasma,Triglycerides (TRIGS) -The
Triglycerides (TRIGS) is intended for the
quantitative in vitro determination of triglyceride
concentration in serum and
plasma,Triglycerides (TRIGS) -The
Triglycerides (TRIGS) is intended for the
quantitative in vitro determination of triglyceride
concentration in serum and plasma,Lipase (LI)-
A Lipase test system is a device intended for
the quantitative in vitro determination of Lipase
in human serum and plasma.,Uric Acid (UA)-
The Uric Acid (UA) is intended for the
quantitative in vitro determination of Uric Acid
concentration in serum, plasma and
urine.,Total-Iron Binding Capacity (TIBC)-The
Total-Iron Binding Capacity (TIBC) reagent is
intended for the quantitative in vitro
determination of total iron-binding capacity
(TIBC) concentration in serum. ,Total-Iron
Binding Capacity (TIBC-The Total-Iron Binding

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No.  License Number  Name  Use  Authority  Class 
Capacity (TIBC) reagent is intended for the
quantitative in vitro determination of total iron-
binding capacity (TIBC) concentration in
serum,Inorganic Phosphorus (PHOS)-The
Inorganic Phosphorous (PHOS) is intended for
the quantitative in vitro determination of
Inorganic Phosphorous in serum, plasma and
urine,Immunoassay Premium Plus -
Immunoassay Premium Plus is intended for in
vitro diagnostic use, in the quality control of
diagnostic assays. The Immunoassay Premium
and Immunoassay Premium Plus is for the
control of accuracy.,Homocysteine (HCY)-A
homocysteine test system is a device intended
for the quantitative in vitro determination of
homocysteine concentration in human
serum,ALBUMIN (ALB)-For the quantitative in-
vitro determination of Albumin concentration in
serum and plasma. This product is suitable for
manual use and on Rx Monza Analyser.,TOTAL
PROTIEN 2 (TP 2)-For the quantitative in vitro
determination of Total Protien concentration in
serum and plasma.,TOTAL PROTIEN-For the
quantitative in vitro determination of Total
Protien concentration in serum and plasma.
,TOTAL BILIRUBIN 2 (T BIL 2)-For the
quantitative in vitro determination of Total
Bilirubin concentration in serum and
plasma.,TOTAL BILIRUBIN (T BIL)-For the
quantitative in vitro determination of Total
Bilirubin concentration in serum and
plasma.,TOTAL BILIRUBIN (T BIL)-For the
quantitative in vitro determination of Total
Bilirubin concentration in serum and plasma.
This product is suitable for manual use.,HDL-
CHOLESTROL (HDL)-For the quantitative in-

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No.  License Number  Name  Use  Authority  Class 
vitro determination of HDL- Cholestrol in serum
and Plasma. ,HDL- CHOLESTROL (HDL)-For
the quantitative in-vitro determination of HDL-
Cholestrol in serum and Plasma. The product is
suitable for manual use and on Rx Monza
analyser.,GLUCOSE (GLUC -HK)-For the
quantitative in-vitro determination of Glucose in
serum Plasma and urine. ,GLUCOSE (GLUC -
PAP)-For the quantitative in-vitro determination
of Glucose in serum Plasma and urine.
,DIRECT BILIRUBIN-For the quantitative in-
vitro determination of Direct Bilirubin in serum
and Plasma. This product is suitable for manual
use.,DIRECT BILIRUBIN-For the quantitative
in-vitro determination of Direct Bilirubin in
serum and Plasma. ,CREATININE (CREA)-For
the quantitative in-vitro determination of
Creatinine in serum Plasma and
urine.,CREATININE (CREA)-For the
quantitative in-vitro determination of Creatinine
in serum Plasma and urine. ,Aspartate
Aminotransferase (AST)-For the quantitative in
vitro determination of Aspartate
Aminotransferase (AST) concentration in serum
and plasma. This product is suitable for manual
use and on the Rx Monza analyser.,Aspartate
Aminotransferase-For the quantitative in vitro
determination of Aspartate Aminotransferase
(AST) concentration in serum and plasma.
,ALANINE AMINOTRANSFERASE (ALT)-For
the quantitative in-vitro determination of
Alkaline Phosphatase in serum and Plasma.
,ALANINE AMINOTRANSFERASE (ALT)-For
the quantitative in-vitro determination of Alanine
Aminotransferase (ALT) in serum and Plasma.
The product is suitable for manual use and on

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No.  License Number  Name  Use  Authority  Class 
the Rx Monza analyser,ALKALINE
PHOSPHATASE (ALP)-For the quantitative in-
vitro determination of Alkaline Phosphatase in
serum and Plasma.,ALKALINE
PHOSPHATASE (ALP)-For the quantitative in-
vitro determination of Alkaline Phosphatase in
serum and Plasma. ,ALBUMIN (ALB)-An
Albumin Test system is a device intended for
the quantitative in-vitro determination of
Albumin concentration in serum and
plasma.,UREA-For the quantitative in vitro
determination of Urea in serum, plasma and
urine.,UREA-For the quantitative in vitro
determination of Urea in serum, plasma and
urine.,UREA-For the quantitative in vitro
determination of Urea in serum, plasma and
urine.This product is suitable for manual use.
,Haemoglobin A1c (HbA1c) -A Haemoglobin
A1c test system is a device intended for the
quantitative in vitro determination of
Haemoglobin A1c concentration in whole
blood,Glucose-6-Phosphate Dehydrogenase
(G-6-PDH)-The Glucose-6-Phosphate
Dehydrogenase (G-6-PDH) is intended for the
quantitative in vitro determination of Glucose-6-
Phosphate Dehydrogenase in
erythrocytes,Cholesterol (CHOL)-The
Cholesterol (CHOL) is intended for the
quantitative in vitro determination of Cholesterol
in serum and plasma,Direct LDL/HDL
Cholesterol Calibrator (D LDL/HDL CAL)-Direct
LDL/HDL Cholesterol Calibrator (D LDL/HDL
CAL) is intended for in vitro use, in the
calibration of Randox HDL & LDL Cholesterol
clearance methods. This calibration material is
based on lyophilised human serum.,Calibration

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Serum -Calibration Serum is for use as a
Calibrator in clinical chemistry assays.
RANDOX Calibration Sera are based on
lyophilised human serum. The concentrations
and activities are suitable for calibration of
clinical chemistry assays on a wide range of
automatic analysers. Constituent
concentrations are available at 2 levels.
,Calcium (Ca)-The Calcium (Ca) is intended for
the quantitative in vitro determination of
Calcium in serum, plasma and urine,H-FABP -
The H-FABP device is intended for the
quantitative in Vitro determination of H-FABP
Concentration in serum and plasma.,IgE
Calibrator Series (IgE CAL SET)-IgE Calibrator
Series (IgE CAL SET) is for use as a Calibrator
in clinical chemistry assays,sLDL-EX “SEIKEN”
(sLDL)-The sLDL-EX “SEIKEN” (sLDL) device
is intended for the quantitative in Vitro
determination of sLDL-EX “SEIKEN”
Concentration in serum and plasma,Sodium
(Na) -The Sodium (Na) device is intended for
the quantitative in Vitro determination of
Sodium Concentration in serum and
plasma,Urinalysis Control (URNAL CONTROL)
-The Urinalysis Control is intended for in vitro
diagnostic use in the quality control of
diagnostic assays. The Urinalysis Control is for
the control of accuracy,D-3 Hydroxybutyrate
(RANBUT) -The D-3 Hydroxybutyrate
(RANBUT) device is intended for the
quantitative in vitro determination of D-3-
Hydroxybutyrate in serum and
plasma.,Microalbumin Liquid Control (mALB
Control)-The Microalbumin Liquid Control
(mALB Control) is intended for in vitro

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No.  License Number  Name  Use  Authority  Class 
diagnostic use in the quality control of
diagnostic assays. ,Lipoprotein (a) Calibrator-
Lipoprotein (a) Calibrator is for use as a
Calibrator in clinical chemistry assays.
RANDOX Lipoprotein (a) Calibrator are based
on lyophilised human serum. ,CK-MB Control -
The CK-MB Control is intended for in vitro
diagnostic use in the quality control of
diagnostic assays. The Human Assayed Multi-
sera is for the control of accuracy ,Rheumatoid
Factor Standard -This product is intended for in
vitro diagnostics use, in the calibration of RF on
clinical chemistry analysers.,Copper (Cu) -The
Copper (Cu) device is intended for the
quantitative in Vitro determination of Copper in
serum and plasma ,CK-MB Calibration Serum -
This product is intended for use in the
calibration of CK-MB assays on clinical
chemistry systems ,Butyryl Cholinesterase
(CHE) -The Butyryl Cholinesterase (CHE)
device for the quantitative in vitro determination
of Butyryl Cholinesterase in serum and
plasma,Assayed Urine Control-The Assayed
Urine Control is intended for in vitro diagnostic
use in the quality control of diagnostic assays.
The Assayed Urine Control is for the control of
accuracy.,: Lipoprotein (a) (LP(a))-The
Lipoprotein (a) (LP(a)) device is intended for
the quantitative in Vitro determination of
Lipoprotein Concentration in serum and plasma
,Immunoglobulin E (IgE) -The Immunoglobulin
E (IgE) device is intended for the quantitative in
Vitro determination of IgE Concentration in
serum and plasma,Immunoassay Speciality
Control -This product is intended for in vitro
diagnostic use, in the quality control of the

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No.  License Number  Name  Use  Authority  Class 
accuracy of Immunoassays on clinical
chemistry systems. This material can be used
to monitor the control of accuracy or the control
of reproducibility of immunoassays.,G6P-DH
Controls-G6P-DH Controls are intended for in
vitro diagnostic use in the quality control of
diagnostic assays. G6P-DH Controls is for the
control of accuracy.,CO2 Total (CO2)-The CO2
Total (CO2) device is intended for the
quantitative in Vitro determination of Carbon
Dioxide in serum and plasma ,Anti-Streptolysin
(ASO) -The Anti-Streptolysin (ASO) device is
intended for the quantitative in Vitro
determination of Anti-Streptolysin-O
concentration in serum ,Anti-Streptolysin (ASO)
-The Anti-Streptolysin (ASO) device is intended
for the quantitative in Vitro determination of
Anti-Streptolysin-O concentration in serum
,Aldolase Control (ALS CONTROL)-The
Aldolase Control (ALS CONTROL) is intended
for in vitro diagnostic use in the Quality Control
of the Aldolase assay AD189,Aldolase (AD) -
The Aldolase (AD) device is intended for the
quantitative in Vitro determination of Aldolase
Concentration in serum and
plasma,Apolipoprotein A1 (APO A-1)-The
Apolipoprotein A1 (APO A-1) device is intended
for the quantitative in Vitro determination of
Apolipoprotein A1 Concentration in serum and
plasma,Complement C3 (C3)-The Complement
C3 (C3) device is intended for the quantitative
in Vitro determination of Complement C3
Concentration in serum and
plasma,Complement C4 (C4)-The Complement
C4 (C4) device is intended for the quantitative
in Vitro determination of Complement C4

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Concentration in serum and plasma,CSF
Control (CSF CONTROL)-The CSF Control
(CSF CONTROL) is intended for in vitro
diagnostic use in the quality control of
diagnostic assays. The CSF Control is for the
control of accuracy,Ferritin (FERR) -The Ferritin
(FERR) device is intended for the quantitative
in Vitro determination of Ferritin Concentration
in serum and plasma,Fructosamine Control
(FRUC CONTROL) -The Fructosamine Control
(FRUC CONTROL) is intended for in vitro
diagnostic use in the quality control of
diagnostic assays. The Fructosamine Control is
for the control of accuracy,Fructosamine
(FRUC)-The Fructosamine (FRUC) device is
intended for the quantitative in Vitro
determination of Fructosamine Concentration in
serum and plasma,Haematology Control 1,2,3
(HAEM CNTL 1,2,3) -The Haematology Control
1,2,3 (HAEM CNTL 1,2,3) is intended for in
vitro diagnostic use in the quality control of
diagnostic assays. The Haematology Control
1,2,3 is for the control of accuracy,H-FABP
CONTROL (H-FABP CONTROL) -The H-FABP
CONTROL (H-FABP CONTROL) is intended for
in vitro diagnostic use in the quality control of
diagnostic assays. The H-FABP CONTROL is
for the control of accuracy ,AMH
CONTROL(RANDOX)-The AMH Control is
intended for use with in vitro diagnostic assays
for the quantitative determination of Anti-
Müllerian Hormone in human serum and
plasma. The AMH Control Level 1 (AMH10509)
is assayed with target values and is suitable for
use on automated analyzers.,SERUM
LOW/HIGH CALIBRATORS(RANDOX)-For in

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
vitro diagnostic use only,ETHANOL
CALIBRATOR AND CONTROL SET (EtOH
CAL/ CONTROL)(RANDOX)-The Randox
Ethanol Calibrator and Control Set is intended
for the calibration and quality control of the
Randox Ethanol assay, which is used for the
quantitative analysis of ethanol in human urine
and serum on the RX series analysers which
includes the RX Daytona and RX Imola
analysers.,ISE DILUENT(RANDOX)-This is
required for the measurement of urine samples.
This product is suitable for use on the RX
series instruments,ETCHING (ETCH)
(RANDOX)-This should be run on a weekly
basis to prevent protein build up. This product
is suitable for use on the RX series
instruments,ISE ELECTRODE(RANDOX)-The
ISE module is intended for the quantitative in
vitro diagnostic determination of Sodium,
Potassium and Chloride in serum and urine.
This product is suitable for use on the RX
series instruments.,ZINC (Zn)(RANDOX)-For
the quantitative in vitro determination of Zinc in
serum, plasma and urine. This product is
suitable for manual use and on the RX monza
analyser. ,URINE LOW/HIGH CALIBRATORS
(ISE CAL U)(RANDOX)-For in vitro diagnostic
use only.,MICROALBUMIN CALIBRATOR
SERIES (mALB CAL)(RANDOX)-Microalbumin
Calibrators are diagnostic products used to
calibrate the Microalbumin Assay. This product
has been developed to guarantee precise
results for the analytical range for various
analysers,HAPTOGLOBIN (HP)(RANDOX)-For
the quantitative in vitro determination of
Haptoglobin in serum. This product is suitable

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
for use on the RX daytona and the RX imola
analysers,HAEMOGLOBIN A1c II (HbA1c II)
(RANDOX)-A Haemoglobin A1c II test system is
a device intended for the quantitative in vitro
determination of Haemoglobin A1c
concentration in whole blood,FRUCTOSAMINE
CALIBRATOR (FRUC CAL)(RANDOX)-This
product is intended for in vitro use in the
calibration of the Randox Liquid Fructosamine
assay on clinical chemistry systems.,ETHANOL
(EtOH)(RANDOX)-The ethanol assay is an in
vitro diagnostic test for the quantitative analysis
of ethanol in human urine and serum on the RX
series instruments which includes the RX
Daytona and the RX imola,BILIRUBIN
ELEVATED SERUM (BIL CONTROL H)
(RANDOX)-Bilirubin Elevated Serum (BIL
CONTROL H) is intended for use in the quality
control of Bilirubin assays on clinical chemistry
analyzers.,APOLIPOPROTEIN CALIBRATOR
(APO CAL)(RANDOX)-APOLIPOPROTEIN
CALIBRATOR (APO CAL) is intended for in-
vitro use in the calibration of Apolipoprotein A-I
and Apolipoprotein B,AMMONIA ETHANOL
CONTROL - LEVEL 3 (NH3/EtOH CONTROL
3)(RANDOX)-The Randox AMMONIA
ETHANOL CONTROL - LEVEL 3 (NH3/EtOH
CONTROL 3) is intended for in vitro diagnostic
use, in the quality control of Ammonia and
Alcohol Assays to monitor precision and to
detect systematic analytical deviations on
clinical chemistry systems ,AMMONIA
ETHANOL CONTROL - LEVEL 2 (NH3/EtOH
CONTROL 2)(RANDOX)-The Randox
AMMONIA ETHANOL CONTROL - LEVEL 2
(NH3/EtOH CONTROL 2) is intended for in vitro

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
diagnostic use, in the quality control of
Ammonia and Alcohol Assays to monitor
precision and to detect systematic analytical
deviations on clinical chemistry
systems,AMMONIA ETHANOL CONTROL -
LEVEL 1 (NH3/EtOH CONTROL 1)(RANDOX)-
The Randox AMMONIA ETHANOL CONTROL -
LEVEL 1 (NH3/EtOH CONTROL 1) is intended
for in vitro diagnostic use, in the quality control
of Ammonia and Alcohol Assays to monitor
precision and to detect systematic analytical
deviations on clinical chemistry
systems,Apolipoprotein B (Apo B)(RANDOX)-
For the quantitative in vitro determination of
Apolipoprotein B (Apo B) in serum and plasma.
This product is suitable for use on Hitachi
704/717/902/911/912.,HbA1c II CALIBRATOR
SET (HbA1c II CAL)(RANDOX)-The HbA1c II
CALIBRATOR SET (HbA1c II CAL) is intended
for use in the calibration of the HbA1c II
assay.,ALDOLASE CALIBRATION SERUM
(ALS CAL)(RANDOX)-The Aldolase Calibration
Serum is intended for in vitro diagnostic use, in
the calibration of the Aldolase assay AD
189.,ISE CLEANER (ISE CLN)(RANDOX)-This
should be run on a weekly basis to prevent
protein build up. This product is suitable for use
on the RX series instruments,REFERENCE
SOLUTION (REF SOLN)(RANDOX)-
REFERENCE SOLUTION (REF SOLUTION) is
required for measuring reference electrode
potential of an ion selective electrode module.
This product is suitable for use on the RX
series instruments.,L SOLUTION (L SOLN)
(RANDOX)-L SOLUTION (L SOLN) is used as
a Calibrator in a two-point calibration. L

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Solution is pumped into the sample port by the
L Solution pump and then positioned in front of
the sensor. This product is suitable for use on
the RX series instruments.,ALBUMIN
STANDARD (BULK)(RANDOX)-The Albumin
test system is a device intended for the
quantitative in Vitro determination of Albumin
Concentration in serum and plasma. This
product is suitable for manual use and on semi-
automated instruments.,CALCIUM STANDARD
(BULK)(RANDOX)-The Calcium test system is
a device intended For the quantitative in vitro
determination of calcium in serum, plasma or
urine. This product is suitable for Manual use
and on semi-automated
instruments,CHOLESTEROL STANDARD
(BULK)(RANDOX)-The Cholesterol test system
is a device intended for the quantitative in vitro
determination of Cholesterol in serum and
plasma. This product is suitable for semi-
automated and manual use.,CREATININE
STANDARD (BULK)(RANDOX)-The Creatinine
test system is a device intended for the
quantitative in Vitro determination of Creatinine
Concentration in serum and plasma. This
product is suitable for manual use and on semi-
automated instruments.,GLUCOSE
STANDARD (BULK)(RANDOX)-The Glucose
test system is a device intended for the
quantitative in Vitro determination of Glucose
Concentration in serum and plasma.This
product is suitable for manual use and on semi-
automated instruments.,HDL/LDL
CHOLESTEROL CALIBRATOR (BULK)
(RANDOX)-The HDL/LDL Cholesterol test
system is a device Intended for Enzymatic

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Clearance assay for the in vitro quantitative
determination of HDL/LDL- Cholesterol in
human serum and plasma. This product is
suitable for use on semi-automated
instruments.,INORGANIC PHOSPHORUS
STANDARD (BULK)(RANDOX)-The Inorganic
Phosphorus test system is a device intended
for the quantitative in Vitro determination of
Inorganic Phosphorous Concentration in serum
and plasma. This product is suitable for manual
use and on semi-automated instruments.,H
SOLUTION (H SOLN)(RANDOX)-Used as a
calibrator in a two-point calibration. H Solution
is aspirated from a sample cup located in a pre-
registered position on the sample carousel.
This product is suitable for use on the RX
series instruments.,URIC ACID STANDARD
(BULK)(RANDOX)-The Uric Acid test system is
a device intended for the quantitative in Vitro
determination of Uric Acid Concentration in
serum and plasma.This product is suitable for
manual use and on semi-automated
instruments,UREA STANDARD (BULK)
(RANDOX)-A urea test system is a device
intended for the quantitative in vitro
determination of urea concentration in serum,
plasma and urine. This product is suitable for
Manual use and on semi-automated
instruments.,TRIGLYCERIDE STANDARD
(BULK)(RANDOX)-The Triglycerides test
system is a device intended for the quantitative
in Vitro determination of Triglycerides
Concentration in serum and plasma.This
product is suitable for manual use and on semi-
automated instruments.,TOTAL PROTEIN
STANDARD (BULK)(RANDOX)-The Total

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Protein test system is a device intended for the
quantitative in Vitro determination of Total
Protein Concentration in serum and
plasma.This product is suitable for manual use
and on semi-automated instruments.,Detergent
-Detergent is a Cleaning Solution of
phosphorous free antibacterial detergent used
for decontamination of the analyser sample
probe and water bath. ,Acid Wash Solution
(Aws)-ACID WASH SOLUTION (AWS) this
product should be used in conjunction with RX
daytona plus reagents to clean probes and
cuvettes.,Alkaline Detergent -Alkaline
Detergent solution which is flushed through the
internal fluidics of the analyser to
decontaminate the cuvette wash heads and
cuvettes,RX Modena ISE Electrode-For the
quantitative in vitro determination of Sodium,
Potassium and Chloride in serum, plasma and
urine. This product is suitable for use on the RX
modena.,ISE Electrode-ISE Electrode is a for
the quantitative in vitro determination of
Sodium, Potassium and Chloride in serum,
plasma and urine.,ISE Cleaning Solution (Soln
Wash)-ISE CLEANING SOLUTION (SOLN
WASH) should be run once a day to prevent
protein build up or at 8-hour intervals if the ISE
module performs more than 50 samples per
day. Cleaning solution may be aspirated from a
sample cup, but the cup must be covered
between use to eliminate evaporation and
ensure accuracy ,Saline Diluent (NS)-Saline
Diluent (NS) should be used in conjunction with
RX Daytona Plus reagents to dilute samples
prior to assay.,Magnesium (Mg)-The
Magnesium (Mg) device is intended for the

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
quantitative in Vitro determination of
Magnesium concentration in serum, plasma
and urine. ,Lipid Control (LPD CONTROL)-Lipid
Control (LPD CONTROL) is supplied at 3
levels, level 1, 2 and 3. Target values and
ranges are supplied for the analytes listed in
the values section at both levels.,Lactate
(LAC)-The Lactate (LAC) device is intended for
the quantitative in Vitro determination of L-
Lactate in plasma and CSF. This product is
suitable for manual use and on semi-
automated instruments. ,HUMAN ASSAYED
MULTI-SERA Level 3 (HUM ASY CONTROL 3)
(NA)-The Human Assayed Multi-Sera (HUM
ASY CONTROL) is intended for in vitro
diagnostic use in the quality control of
diagnostic assays. The Human Assayed Multi-
sera is for the control of accuracy,Lactate
(LAC)-The Lactate (LAC) device is intended for
the quantitative in Vitro determination of L-
Lactate in plasma and CSF. This product is
suitable for manual use and on semi-
automated instruments.,HUMAN ASSAYED
MULTI-SERA level 2 (HUM ASY CONTROL 2)
(NA)-The Human Assayed Multi-Sera (HUM
ASY CONTROL) is intended for in vitro
diagnostic use in the quality control of
diagnostic assays. The Human Assayed Multi-
sera is for the control of accuracy,ISE Urine
Diluent (ISE DIL URN)-ISE Urine Diluent (ISE
DIL URN) is required for Urine Samples. Urine
Samples must be diluted by a factor of 10 to
perform urine measurement. The host analyser
will mix the diluent and sample before
dispensing the diluted sample into the ISE
module. ,MATERNAL CONTROL - LEVEL 1

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
(MATERNAL CONTROL 1)(NA)-The Maternal
Control product is intended for in vitro use, in
the quality control of Alpha-fetoprotein, Free
Beta hCG, Free Estriol, Human Chorionic
Gonadotropin, Inhibin A and PAPP-A methods
on clinical chemistry systems,ISE Calibrator B
(CAL B) -ISE Calibrator B (CAL B) used as a
second Calibrator in a two-point calibration.
Calibrator B is aspirated from a sample cup at
position 18 on the analyser ASP tray at least
once every 8 hours depending on the
laboratories schedule. This product is suitable
for use on the RX series instruments which
includes the RX daytona and the RX imola.
,ISE Calibrator A (CAL A)-ISE Calibrator A (CAL
A) used as a wash solution and single point
Calibrator. Calibrator A is pumped into the
sample port by the Calibrator A pump and then
positioned in front of the sensor. This product is
suitable for use on the RX series instruments
which includes the RX daytona and the RX
imola.,Hemoglobin A1c Calibrator -This product
is intended for in vitro diagnostic use in the
calibration of HbA1c on clinical chemistry
systems,Creatine Kinase (CK-MB)-The
Creatine Kinase (CK-MB) device is intended for
the quantitative in Vitro determination of CK-MB
Concentration in serum and plasma,Tri-Level
Cardiac Control (Crd Control 1, 2, 3)-The Tri-
Level Cardiac Control (CRD CONTROL 1, 2, 3)
is intended for in vitro diagnostic use, in the
quality control of Cardiac Markers on clinical
chemistry and Immunoassay systems.,serum
diluent -Serum Diluent (DIL SM) is for
reconstitution of Randox Quality Control
Sera.,RX WASH CONCENTRATE (WASH

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
conc. 3) -RX WASH CONCENTRATE (WASH
conc. 3) is a Cleaning Solution for the RX
series that should be connected via wash line
3. This product has been designed particularly
for the RX series analysers and is a phosphate
free solution with an antibacterial effect.,RX
WASH CONCENTRATE (WASH conc. 2) -RX
WASH CONCENTRATE (WASH conc. 2) is a
Cleaning Solution for the RX series that should
be connected via wash line 2. This product has
been designed particularly for the RX series
analysers and is a phosphate free solution with
an antibacterial effect.,RX WASH
CONCENTRATE (WASH conc. 1) -RX WASH
CONCENTRATE (WASH conc. 1) is a Cleaning
Solution for the RX series that should be
connected via wash line 1. This product has
been designed particularly for the RX series
analysers and is a phosphate free solution with
an antibacterial effect. ,Normal Saline (NS)-
Normal Saline (NS) product should be used in
conjunction with RX series reagents to dilute
samples prior to assay.,Liquid Protein
Calibrators-Liquid Protein Calibrators are an in
vitro diagnostic product used for the calibration
of various assays. ,ISE Detergent -ISE
Detergent is required for maintenance of the
ISE unit on the RX modena analyser.,Buffer
and L Solution-The ISE Buffer & L Solutions are
required for the running of the ISE unit on the
RX Modena analyser.,Buffer and L Solution -
The ISE Buffer & L Solutions are required for
the running of the ISE unit on the RX Modena
analyser.,Creatine Kinase (CK-NAC)-The
Creatine Kinase (CK-NAC) reagent family are
for the quantitative in vitro determination of

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
Creatine Kinase in serum or plasma,Creatine
Kinase (CK-NAC)-The Creatine Kinase (CK-
NAC) reagent family are for the quantitative in
vitro determination of Creatine Kinase in serum
or plasma,C1 SOLUTION (C1 SOLN) -C1
SOLUTION (C1 SOLN) has been designed
particularly for the RX daytona analyser and is
a weak bleach solution.,C1 SOLUTION (C1
SOLN)-C1 SOLUTION (C1 SOLN) has been
designed particularly for the RX daytona
analyser and is a weak bleach solution.,Bile
Acids (TBA)-The Bile Acids (TBA) device is
intended for the quantitative in vitro
determination of Total Bile Acids in serum and
plasma ,Bile Acids (TBA)-The Bile Acids (TBA)
device is intended for the quantitative in vitro
determination of Total Bile Acids in serum and
plasma ,Acid Wash Solution (Aws) -ACID
WASH SOLUTION (AWS) this product should
be used in conjunction with RX daytona plus
reagents to clean probes and cuvettes.,Wash
Solution-WASH SOLUTION this product should
be used in conjunction with RX modena
reagents to clean probes and
cuvettes.,MATERNAL CONTROL - LEVEL 3
(MATERNAL CONTROL 3)(NA)-The Maternal
Control product is intended for in vitro use, in
the quality control of Alpha-fetoprotein, Free
Beta hCG, Free Estriol, Human Chorionic
Gonadotropin, Inhibin A and PAPP-A methods
on clinical chemistry systems,MATERNAL
CONTROL - LEVEL 2 (MATERNAL CONTROL
2)(NA)-The Maternal Control product is
intended for in vitro use, in the quality control of
Alpha-fetoprotein, Free Beta hCG, Free Estriol,
Human Chorionic Gonadotropin, Inhibin A and

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
PAPP-A methods on clinical chemistry
systems,IgG(RANDOX)-An IgG test system is a
device intended for the quantitative in vitro
determination of immunoglobulin G (IgG)
concentration in serum and plasma. This
product is suitable for use on the RX series
instruments which includes the RX daytona and
RX imola.,EVIDENCE MULTISTAT
ANALYSER(RANDOX)-The Evidence
MultiSTAT is a benchtop system for Randox
biochip assays. It is intended for in-vitro
qualitative, determination of various diagnostic
markers, drugs of abuse and drug residues in
oral fluid, serum, plasma, whole blood, urine,
milk, or other sample matrix types stipulated in
the product application. Virtually all
immunoassay processes are performed
automatically in a self-contained and sealed
biochip cartridge which holds the biochips, the
reagents, wash buffer and other fluids required
for the test to be conducted. Assay results are
determined by the generation of light from
chemiluminescent reactions that take place on
Discrete Test Regions (DTRs) (reaction sites)
on the surface of the biochip. The light output is
detected by a Charge Coupled Device (CCD)
camera in the Evidence MultiSTAT system
which, together with the analyser software, is
used to quantify the light output and produce
meaningful results. ,EVIDENCE+
ANALYSER(RANDOX)-The Randox Evidence+
analyser is a fully automated, continuous
access immunoanalyser using protein Biochip
array technology. It is intended for the in-vitro
qualitative, semi-quantitative or fully
quantitative determination of various diagnostic

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No.  License Number  Name  Use  Authority  Class 
markers in serum, plasma, urine, whole blood,
oral fluids, and other forensic matrices.
Immunoassays are performed on the surface of
a Biochip, which is transported to various
treatment stations within the analyser. Assay
endpoint is the generation of light from a
chemiluminescent reaction which is measured
using a Charge Coupled Device (CCD) camera.
Imaging technology is used to quantify the light
output from discrete test regions (reaction sites)
on the Biochip surface. ,RX DAYTONA PLUS
ANALYSER(RANDOX)-The Randox RX
Daytona Plus is a fully automated, random
access, clinical chemistry benchtop analyser
complete with dedicated analyser software
used for the determination of clinical chemistry
parameters in serum, plasma, supernatants,
urine, and CSF sample types. A barcode
system is used for the rapid identification and
management of patient samples, reagents, and
QC samples. The RX Daytona+ is capable of
270 photometric tests per hour and up to 450
including ISE. Before using this product,
personnel must have successfully completed
the Randox, RX Daytona+ training course. ,RX
IMOLA ANALYSER(RANDOX)-RX Imola is an
automated clinical chemistry analyser complete
with dedicated analyser software. Software
functions of the analyser include the facility to
interact with a host computer for direct
download of test method selection details for
individual samples. A barcode system is used
for the rapid identification of patient samples,
reagents and QC samples. The RX Imola
analyser is capable of 400 tests per hour, and
560 with ISE. The RX Imola is intended for the

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
in-vitro determination of various diagnostic
markers in serum, plasma, CSF, urine and
supernatants patient samples.,LIQUID URINE
CONTROL - LEVEL 3(RANDOX)-The Randox
Liquid Urine Control - Level 3 is intended for in
vitro diagnostic use, in the quality control of
Amylase, Calcium, Chloride, Cortisol,
Creatinine, Glucose, hCG pregnancy,
Magnesium, Microalbumin, Osmolality, pH,
Phosphate Inorganic, Potassium, Protein Total,
Sodium, Specific Gravity, Urea and Uric Acid
(Urate) on clinical chemistry systems. The
Liquid Urine Control is for the control of
accuracy.,GLUTAMATE
DEHYDROGENASE(RANDOX)-For the
quantitative in vitro determination of Glutamate
Dehydrogenase (GLDH) in serum. This product
is suitable for manual use and on the Rx Monza
analyzer.,IgM(RANDOX)-For the quantitative in
vitro determination of IgM in serum and plasma.
This product is suitable for use on the RX
series instruments which includes the RX
daytona and RX imola.,RX MISANO
ANALYSER(RANDOX)-The RX Misano is a low
throughput, semi-automated, benchtop clinical
chemistry analyser that is capable of
conducting analytical tests using either a
dedicated flow cell or conventional cuvettes.
The RX Misano is supplied with dedicated
analyser software. It is intended for in-vitro
qualitative, semi-quantitative or fully
quantitative determination of various diagnostic
markers in serum, urine, plasma, whole blood,
honey, and wine samples.,RX MODENA
ANALYSER (RANDOX)-The RX Modena is a
high throughput, fully automated, floor standing

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
clinical chemistry analyser that is capable of
performing 1200 tests per hour including ISE.
The RX Modena is supplied with dedicated
analyser software. It is intended for in-vitro
qualitative, semi-quantitative or fully
quantitative determination of various diagnostic
markers in serum, urine, plasma, and whole
blood patient samples.,RX Monaco
Analyser(RANDOX)-The RX Monaco is a fully
automated random-access clinical chemistry
analyser that is capable of performing 170 tests
per hour. The RX Monaco is supplied with
dedicated software designed to guide the user
through the operational process. The software
allows the analyser to interact with a host
computer for direct download of selected test
methods for individual samples and QC results.
An on-board barcode system is used for rapid
identification of patient samples and monitoring
reagents. It is intended for testing of a wide
range of analytes in serum, plasma, urine, CSF,
and supernatants patient samples.,EVIDENCE
INVESTIGATOR ANALYSER(RANDOX)-The
Randox Evidence Investigator is a manual
benchtop clinical chemistry analyser with
dedicated analyser software. A handheld
barcode reader is supplied with the system to
read the kit barcodes and barcodes of patient
sample tubes. This transfers all details to the
system software. The Randox Evidence
Investigator is intended for the in vitro
determination of various diagnostic markers in
faeces, feed, honey, milk, oral fluid, plasma,
serum, tissue, urine, and whole blood samples.
The Evidence Investigator is capable of up to
23 tests per 5x5 array, and 45 tests per 7x7

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
array, therefore the maximum output of tests
per hour is based on the number of samples
multiplied by the number of tests per
array.,LIQUID URINE CONTROL - LEVEL
2(RANDOX)-The Randox Liquid Urine Control
Level 2 is intended for in vitro diagnostic use, in
the quality control of Amylase, Calcium,
Chloride, Cortisol, Creatinine, Glucose, hCG
pregnancy, Magnesium, Microalbumin,
Osmolality, pH, Phosphate Inorganic,
Potassium, Protein Total, Sodium, Specific
Gravity, Urea and Uric Acid (Urate) on clinical
chemistry systems. The Liquid Urine Control is
for the control of accuracy.,IgA(RANDOX)-For
the quantitative in vitro determination of IgA in
serum and plasma. This product is suitable for
use on the RX series instruments, which
includes the RX Daytona and RX
Imola.,GLYCEROL CONTROL(RANDOX)-This
product is intended for in vitro diagnostic use in
the quality control of Glycerol Assays on clinical
chemistry systems. The Glycerol Control is for
the control of accuracy and precision.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1093 IMP/IVD/2020/000585 Randox Laboratories PHENOBARBITAL (PHB)(RANDOX)-For the CDSCO Class C

India Pvt Ltd quantitative in vitro determination of
Phenobarbital in human serum. This product is
suitable for use on the RX series instruments
which includes the RX daytona and RX
imola.,RANDOX CRP KIT FOR WHOLE
BLOOD SAMPLES(RANDOX)-VeraSTAT CRP
Test is an in vitro near-patient diagnostic test for
the quantitative determination of Creactive
protein (CRP) from whole blood to assess the
inflammatory status of the body. VeraSTAT
CRP Kit is to be used with semi-automated
VeraSTAT Analyzer by healthcare
professionals.,DOA ULTRA URINE ARRAY
CONTROLS (DOA ULTRA URN CONTROL)
(RANDOX)-Randox DOA Ultra Urine controls
are intended for use as an assayed quality
control in the routine monitoring of accuracy
and precision for the analytes listed in this
insert. They are buffer based containing a
variety of analytes at 2 different
levels.,CYTOKINE CONTROL (CTK)
(RANDOX)-Randox Cytokine controls are
intended for use as an assayed quality control
in the routine monitoring of accuracy and
precision for the analytes listed in this
insert.,DOA ULTRA WHOLE BLOOD
CONTROLS (DOA ULTRA WB CONTROLS)
(RANDOX)-Randox DOA Ultra WB controls are
intended for use as an assayed quality control
in the routine monitoring of accuracy and
precision for the analytes listed in this insert.
They are buffer based containing a variety of
analytes at 2 different levels,CYTOKINE &
GROWTH (CTK)(RANDOX)-The Evidence
Investigator™ Cytokine & Growth Factors Array
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No.  License Number  Name  Use  Authority  Class 
is to be used for the simultaneous quantitative
detection of multiple related cytokine
immunoassays (in parallel) from a single
sample.,C-REACTIVE PROTEIN (CRP)-The C-
Reactive Protein (CRP) is intended for the
quantitative in vitro determination of C-Reactive
Protein concentration in serum and plasma.
This product is suitable for manual use and on
automated instruments. ,C-REACTIVE
PROTEIN (CRP)-The C-Reactive Protein
(CRP) is intended for the quantitative in vitro
determination of C-Reactive Protein
concentration in serum and plasma. This
product is suitable for manual use and on
automated instruments. ,Coagulation Controls-
The Coagulation Controls are intended for in
vitro diagnostic use in the quality control of
diagnostic assays. The Coagulation Controls
are for the control of accuracy,CRP Calibrator
Series-This product is intended for in vitro
diagnostic use in the calibration of CRP assays
on clinical chemistry systems. Constituent
concentrations are available at 6 levels.
,Therapeutic Drug Calibrator (TDM CAL)-
Therapeutic Drug Calibrator (TDM CAL) is
intended for use in the calibration of therapeutic
drug assays.,Therapeutic Drug Control (TDM
CONTROL)-This product is intended for in vitro
diagnostic use, in the quality control of drug
residue analysis on clinical chemistry
systems,Valproic Acid (VPA)-Valproic Acid
(VPA) reagent is intended for the quantitative in
vitro determination of Valproic Acid in human
serum,Phenytoin (PHT)-The Phenytoin (PHT)
device is intended for the quantitative in Vitro
determination of Phenytoin Concentration in

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
serum and plasma,β2 Microglobulin (B2M)-The
β2 Microglobulin (B2M) device is intended for
the quantitative in Vitro determination of β2
Microglobulin Concentration in serum and
plasma,Carbamazepine (CBZ)-The
Carbamazepine (CBZ) device is intended for
the quantitative in Vitro determination of
Carbamazepine Concentration in serum and
plasma,CRP Control (hs & liquid) (CRP
CONTROL) -The CRP Control (hs & liquid)
(CRP CONTROL) is intended for in vitro
diagnostic use in the quality control of
diagnostic assays. The CRP Control (hs &
liquid) is for the control of accuracy,Blood Gas
Control (BG CONTROL)-The Blood Gas
Control (BG CONTROL) are intended for in
vitro diagnostic use in the quality control of
diagnostic assays. The Blood Gas Control (BG
CONTROL) are for the control of
accuracy,DRUGS OF ABUSE ARRAY
BLOOD(NA)-The Evidence MultiSTAT DOA
Blood Assays are tests for the qualitative
determination of the parent molecule and
metabolites of drugs in human whole blood.
They are competitive enzyme immunoassays
run on the automated biochip array analyser,
Evidence MultiSTAT.,DOA ULTRA URINE
ARRAY (DOA ULTRA URN)(NA)-The Evidence
Investigator™ DOA Ultra Urine assays are tests
for the semi-quantitative determination of the
parent molecule and metabolites of drugs in
human urine. They are competitive enzyme
immunoassays run on the biochip array
analyzer, Evidence Investigator™.,DOA ULTRA
WHOLE BLOOD ARRAY (DOA ULTRA WB)
(NA)-The Evidence Investigator™ DOA ULTRA

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
WB assays are tests for the semi-quantitative
determination of the parent molecule and
metabolites of drugs in human blood. They are
competitive enzyme immunoassays run on the
biochip array analyzer, Evidence
Investigator™.,DRUGS OF ABUSE ARRAY
ORAL FLUID II(NA)-The Evidence MultiSTAT
DOA Oral Fluid II Assays are tests for the
qualitative determination of the parent molecule
and metabolites of drugs in human oral fluid.
They are competitive enzyme immunoassays
run on the automated biochip array analyser,
Evidence MultiSTAT. ,Drugs of Abuse Array
Urine(NA)-The Drugs of Abuse Array Urine are
tests for the qualitative determination of the
parent molecule and metabolites of drugs in
human urine. They are competitive enzyme
immunoassays run on the automated biochip
array analyser, Evidence MultiSTAT. ,DRUGS
OF ABUSE ARRAY URINE II(NA)-The
Evidence MultiSTAT DOA Urine II Assays are
tests for the qualitative determination of the
parent molecule and metabolites of drugs in
human urine. They are competitive enzyme
immunoassays run on the automated biochip
array analyser, Evidence MultiSTAT.,NEW
PSYCHOACTIVE SUBSTANCES I URINE
(NPS I URN)(NA)-The Evidence Investigator™
New Psychoactive Substances II assays are in
vitro tests for the semi-quantitative
determination of the parent molecule and
metabolites of classic designer drugs in human
urine.,NEW PSYCHOACTIVE SUBSTANCES II
URINE (NPS II URN)(NA)-The Evidence
Investigator™ New Psychoactive Substances II
assays are in vitro tests for the semi-

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
quantitative determination of the parent
molecule and metabolites of classic designer
drugs in human urine.,NEW PSYCHOACTIVE
SUBSTANCES I URINE CONTROLS (NPS I
URN CONTROLS)(NA)-Randox NPS I URN
controls are intended for use as an assayed
quality control in the routine monitoring of
accuracy and precision for the analytes listed in
this insert. They are buffer based containing a
variety of analytes at 2 different levels.,NEW
PSYCHOACTIVE SUBSTANCES II URINE
CONTROLS (NPS II URN)(NA)-Randox NPS II
URN controls are intended for use as an
assayed quality control in the routine monitoring
of accuracy and precision for the analytes listed
in this insert. They are buffer based containing
a variety of analytes at 2 different levels.

1094 IMP/IVD/2020/000587 ACCUREX Uric Acid Test Strip (BeneCheck)-The uric acid CDSCO Class B
BIOMEDICALS PVT. test strip is intended to measure the uric acid
LTD. levels in fingertip capillary whole blood for self-
testing with the meter.,Benecheck
Meter(BeneCheck)-Measuring blood glucose in
fresh capillary whole blood from fingertip, palm,
or forearm. • Measuring total cholesterol / uric
acid in fresh capillary whole blood from
fingertip. • The meter can be used by
laypersons or healthcare professionals. • In
vitro diagnostic use only.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1095 IMP/IVD/2020/000591 M/S. MEDSOURCE ß2-Glycoprotein 1 (ß2GP1) IgM-In Vitro CDSCO Class B
OZONE Diagnostic test for determination of ß2GP1 1
BIOMEDICALS PVT IgM auto antibodies in Human
LTD Serum/Plasma,dsDNA IgG-In Vitro Diagnostic
test for determination of dsDNA IgG auto
antibodies in Human Serum/Plasma,Cardiolipin
IgG-In Vitro Diagnostic test for determination of
Cardiolipin IgG auto antibodies in Human
Serum/Plasma,ANA Screen 8 IgG-In Vitro
Diagnostic test for determination of Anti Nuclear
Antibodies in Human
Serum/Plasma,Myeloperoxidase (MPO) IgG-In
Vitro Diagnostic test for determination of MPO
auto antibodies in Human Serum/Plasma,tissue
Transglutaminase (tTG) IgA-In Vitro Diagnostic
test for determination of tTG IgA auto
antibodies in Human Serum/Plasma,Proteinase
3 (PR3) IgG-In Vitro Diagnostic test for
determination of PR3 auto antibodies in Human
Serum/Plasma,Cardiolipin IgM-In Vitro
Diagnostic test for determination of Cardiolipin
IgM auto antibodies in Human
Serum/Plasma,SS-A/Ro 60 IgG-In Vitro
Diagnostic test for determination of SSA/Ro60
auto antibodies in Human Serum/Plasma,ß2-
Glycoprotein 1 (ß2GP1) IgG-In Vitro Diagnostic
test for determination of ß2GP1 IgG auto
antibodies in Human Serum/Plasma

1096 IMP/IVD/2020/000592 Brundas Trading Lyse(Zybio)-For cell classification count or CDSCO Class B
Consortium Pvt. Ltd. hemoglobin quantitative
measurement.,Lyse(Zybio)-For cell
classification count or hemoglobin quantitative
measurement.,Diluent(Zybio)-The Diluent is
used for counting and sizing blood cells.

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1097 IMP/IVD/2020/000597 Asvins Lifetechnologies U-TOP™ COVID-19 Detection Kit-The U-TOP CDSCO Class C
Private Limited COVID-19 Detection Kit is a one-step real-time
RT-PCR test intended for the qualitative
detection of nucleic acid from SARS-CoV-2 in
oropharyngeal and nasopharyngeal swab
specimens, anterior nasal and mid-turbinate
nasal swabs, nasopharyngeal wash/aspirate or
nasal aspirate specimens and sputum from
individuals who are suspected of COVID-19 by
their healthcare provider.

1098 IMP/IVD/2020/000598 TULIP DIAGNOSTICS Rea IQC TB (Total Blood) Kit for Blood CDSCO Class D
PRIVATE LIMITED Grouping(Rea IQC TB Kit)-Rea IQC Total Blood
Kit for internal quality control for
immunohaematology testing.,ReaCell Panel for
antibody identification(ReaCell Panel)-ReaCell
Panel are used for antibody
identification..,ReaCell I, II, III for antibody
detection(ReaCell I, II, III)-ReaCell I, II, III are
used for antibody detection.

1099 IMP/IVD/2020/000600 Topaim Properties Novel Coronavirus (2019-nCov) RT – PCR CDSCO Class C
Private Limited Detection Kit(Fosun 2019 – nCov qPCR)-This
Product is intended for the rapid detection of
2019-nCov by TaqMan multiplex real-time PCR
in human throat swab or sputum samples

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 

1100 IMP/IVD/2020/000602 KDH BIOMEDICALS Rotavirus(CERTEST Rotavirus)-For the CDSCO Class C

PVT LTD qualitative detection of Rotavirus in stool
samples. ,Adenovirus(CERTEST Adenovirus)-
For the qualitative detection of Adenovirus in
stool samples.,Norovirus Gl + Gll(CERTEST
Norovirus Gl + Gll)-For the simultaneous
qualitative detection of Norovirus genogroup I
and II (Gl and Gll) in stool samples.,Rota +
Adeno + Astro + Noro GI/GII(CERTEST Rota +
Adeno + Astro + Noro GI/GII)-For the
simultaneous qualitative detection of Rotavirus,
Adenovirus, Astrovirus and Norovirus in stools
samples. ,Listeria(CERTEST Listeria)-For the
qualitative detection of Listeria monocytogenes
in stool samples.,H.Pylori(CERTEST H.Pylori)-
For the qualitative detection of Helicobacter
pylori in stool samples.,Entamoeba(CERTEST
Entamoeba)-For the qualitative detection of
Entamoeba spp. In stool
samples.,RSV(CERTEST RSV)-For the
qualitative detection of Respiratory Syncytical
Virus Antigen from nasal swab,
nasopharyangeal wash or aspirate
specimens.,Adenovirus Resp(CERTEST
Adenovirus Resp)-For the qualitative detection
of Adenovirus from nasal swab,
nasopharyngeal wash or aspirate
specimens.,Campylobacter(CERTEST
Campylobacter)-For the qualitative detection of
Campylobacter spp. Stool samples and
Campylobacter spp. Suspected colonies in
stool culture.,Yersinia entercolitica 0 : 3 + 0 :
9(CERTEST Yersinia entercolitica 0 : 3 + 0 : 9)-
For the simultaneous qualtiative detection of
Yersina enterocolitica serotypes 0 : 3 and 0 : 9
in stool samples and Yersinia suspected
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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
colonies in stool culture.,Crypto(CERTEST
Crypto)-For the qualitative detection of
Cryptosporidium in stool
samples.,Giardia(CERTEST Giardia)-For the
qualitative detection of Giardia in stool
samples.,STREP A(CERTEST STREP A)-For
the qualitative detection of Group A
Streptococcal from throat swabs and suspected
Group A Streptococcal colonies recovered from
culture.,Legionella(CERTEST Legionella)-For
the qualitative detection of Legionella
pneumophilla in human urine
samples.,Calprotectin Turbilatex
Combo(Calprotectin Turbilatex Combo)-
Calprotectin Turbilatex is a latex turbidimetric
assay only for the quantitative detection of
calprotectin in human solid stool samples (not
to be used for body fluid as blood, serum,
plasma, urine, cerebrospinal fluid, oral fluid,
synovial fluid or empyema fluid).,Calprotectin
Turbilatex Sample Collection Vials(Sample
Dilution Vials MC)-Sample Diluent Vials is a
single use vial containing diluent for faecal
samples dilution. For professional in vitro
diagnostics use only.,Crypto +
Giardia(CERTEST Crypto + Giardia)-For the
simultaneous qualitative detection of
Cryptosporidium and Giardia in stool
samples.,FOB(CERTEST FOB)-For the semi-
quantitative determination of human
heamoglobin (hHb) in stool samples.,EHEC
VT1 + VT2(CERTEST EHEC VT1 + VT2)-For
the simultaneous qualitative detection of
Veroxins 1 and 2 (VT1 and VT2) produced by
E. coli in stool sample and E. coli suspected
colonies in stool culture.,Calprotectin 50 +

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S. License Holder Device Name(Brand Name)-Intended Approving Device

No.  License Number  Name  Use  Authority  Class 
200(CERTEST Calprotectin 50 + 200)-For the
simultaneous semi-quantitative detection of
human calprotectin (hCp) in stool
samples,Clostridium difficile GDH + Toxin A +
B(CERTEST Clostridium difficile GDH + Toxin A
+ B)-For the simultaneous qualitative detection
of Clostridum difficile Glutamate
Dehydrogenase (GDH), Toxin A and Toxin B in
stool samples.

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