MATERIAL SAFETY DATA SHEET
SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING
1.1 Product identifier
Trade name CK Reagent Kit (Phosphocreatine Substrate method)
Model name CK Reagent Kit (Phosphocreatine Substrate method)
1.2 Relevant identified uses of the substance or
mixture and uses advised against
Identified use(s) In vitro diagnostic reagent. For professional use only.
1.3 Details of the supplier of the safety data sheet
Company Identification Jilin Getein Biotech Co. Ltd.
Address: No. 1399, Ya'an Road, Beihu Science and Technology Development
Zone, Changchun, Jilin, China
Telephone +86 25 68568508
Fax +86 25 68568500
E-Mail tech@getein.com.cn overseas@getein.com.cn
1.4 Emergency telephone number +86 25 68569089
SECTION 2: HAZARDS IDENTIFICATION
2.1 NEPA ratings (scale 0-4)
Health =0; Fire = 0; Reactivity = 0
2.2 Classifcation of the substance or mixture
Classifcation accroding to GHS: Not calssified as dangerous goods
Classifcation according to Regulation (EC) No 1272/2008: The product is not classified according to the CLP regulation.
Classifcation according to OSHA Hazard Communication Standard (29 CFR 1910.1200):
The product is not classified according to OSHA Hazard Communication Standard (29 CFR 1910.1200)
Labeling according to GHS and GLP: Not applicable
Hazard pictograms: Not applicable
Signal word: Not applicable
Hazard statements: This mixture is cosidered as non dangerous mixture.
Precautionary statements: Not applicable
Other hazards: See section 11
Results of PBT and vPvB assessment: Not applicable
Potential Chronic Health Effects:
CARCINOGENIC EFFECTS: This material is not a carcinogen. Classified NONE by NTP, OSHA and by IARC.
MUTAGENIC EFFECTS: Not available. Not applicable
. TERATOGENIC EFFECTS: Not available. Not applicable
SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS
3.1 Mixtures
Description: In vitro diagnostic reagent test device.
Based on clinical chemistry reaction.
Dangerous components: None
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MATERIAL SAFETY DATA SHEET
3.2 Additional Information Store in at 2 to 8°C.
See section 16.
SECTION 4: FIRST AID MEASURES
4.1 Description of first aid measures
General information The following first aid measures are only relevant in the event
of serious misuse, whereby the device is disassembled and
there is exposure to the chemicals in the test strip.
Inhalation Supply fresh air; consult doctor in case of complaint.
Skin Contact Wash skin with soap and water.
Eye Contact Rinse cautiously with water for several minutes. Consult
doctor in case of complaint.
Ingestion Wash out mouth with water. Consult a doctor.
4.2 Most important symptoms and effects, both None.
acute and delayed
4.3 Indication of the immediate medical attention None.
and special treatment needed
SECTION 5: FIRE-FIGHTING MEASURES
5.1 Extinguishing media
Suitable Extinguishing Media CO2, powder or water spray. Fight larger fires with water
spray or alcohol resistant foam.
5.2 Special hazards arising from the substance or In case of fire, the following can be released: Hazardous
mixture fumes and vapours.
5.3 Advice for fire-fighters Use fire-extinguishing methods suitable to surrounding
conditions.
Wear full protective suit and self-contained breathing
aparatus (SCBA) when extinguishing fires.
SECTION 6: ACCIDENTAL RELEASE MEASURES
6.1 Personal precautions, protective equipment Refer to Section 8 for protective measures when handling the
and emergency procedures spillage.
6.2 Environmental precautions None know.
6.3 Methods and material for containment and Collect material and dispose of as waste according to
cleaning up Section 13
6.4 Reference to other sections 8, 13
SECTION 7: HANDLING AND STORAGE
7.1 Precautions for safe handling Avoid contact with the eyes, skin and mucous membranes.
Keep out of reach of children.
Specimens should be handled as potentially infectious
materials. Refer to Directive 2000/54/EC for information on
handling biohazardous materials.
Wash hands before breaks and after work.
Clean work areas with hypochlorite or other disinfecting
agent.
7.2 Specific end use(s) Use as per instructions for use.
SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
Ventilation and Engineering controls:No special ventilation and engineering controls are required.
Respiratory Protection: No special respiratory protection is required for use of these products. If respiratory protection is
needed, use only protection applicable U.S. State or EU regulations.
Body Protection: General protective clothing.
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Eye Protection:
Hand protection Disposable gloves. (EN374).
Protective Gloves:
Eye/face protection Safety glasses recommended. (EN166)
SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES
9.1 Information on basic physical and chemical
properties
Appearance Laminated test strip consisting of solid support materials
impregnated with dried chemical / biochemical reagents.
Colour White.
Odour No odour.
Odour Threshold (ppm) Not applicable
pH (Value) Not determined
Melting Point (°C) / Freezing Point (°C) Not deter Not determined
Boiling point/boiling range (°C): Not determined
Flash Point (°C) Not applicable
Evaporation rate (BA = 1) Not applicable
Flammability (solid, gas) Not determined
Explosive limit ranges Not applicable
Vapour Pressure (mm Hg) Not applicable
Vapour Density (Air=1) Not applicable
Density (g/ml) Not determined
Solubility (Water) Not determined
Solubility (Other) Not determined
Partition Coefficient (n-Octanol/water) Not determined
Auto Ignition Temperature (°C) Not determined
Decomposition Temperature (°C) Not determined
Viscosity (mPa.s) Not determined
Explosive properties Not explosive.
Oxidising properties `
9.2 Other information Not available
SECTION 10: STABILITY AND REACTIVITY
10.1 Reactivity
None known.
10.2 Chemical stability The product is stable in accordance with the recommended
storage conditions.
10.3 Possibility of hazardous reactions None known. Hazardous polymerisation will not occur.
10.4 Conditions to avoid None
10.5 Incompatible materials None known..
10.6 Hazardous Decomposition Product(s) Not oxidising.
Version:GP202404
CK Reagent Kit (Phosphocreatine Substrate method) 3/6 Date: 2024/04/01
MATERIAL SAFETY DATA SHEET
SECTION 11: TOXICOLOGICAL INFORMATION
11.1 Information on toxicological effects
11.1.1 Mixtures
Acute toxicity Based upon the available data, the classification criteria are
not met.
Irritation Based upon the available data, the classification criteria are
not met.
Corrosivity Based upon the available data, the classification criteria are
not met.
Sensitisation Based upon the available data, the classification criteria are
not met.
Repeated dose toxicity No data
Carcinogenicity Based upon the available data, the classification criteria are
not met.
Mutagenicity No data
Toxicity for reproduction Based upon the available data, the classification criteria are
not met.
STOT-single exposure Based upon the available data, the classification criteria are
not met.
STOT-repeated exposure Based upon the available data, the classification criteria are
not met.
Aspiration hazard Based upon the available data, the classification criteria are
not met.
Health Effects and Symptoms
Skin Contact No significant harmful effects anticipated
Eye Contact No significant harmful effects anticipated
Ingestion No significant harmful effects anticipated
11.2 Other information Not applicable
SECTION 12: ECOLOGICAL INFORMATION
12.1 Toxicity The product does not contain significant quantities of
ingredients that are environmentally toxic.
12.2 Persistence and degradability The product is recyclable and biodegradable.
12.3 Bioaccumulative potential None anticipated.
12.4 Mobility in soil The product is predicted to have low mobility in soil.
12.5 Results of PBT and vPvB assessment Not applicable
12.6 Other adverse effects Not applicable
SECTION 13: DISPOSAL CONSIDERATIONS
13.1 Waste treatment methods
Product: To ensure compliance we recommend that you contact the relevant
(local) authorities and/or an approved waste-disposal
company for information.
European waste catalogue: 18 01 03.
Packaging: Disposal should be in accordance with local, state or
national legislation.
Packaging materials is recyclable or biodegradable.
Contact your local service providers for further information.
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CK Reagent Kit (Phosphocreatine Substrate method) 4/6 Date: 2024/04/01
MATERIAL SAFETY DATA SHEET
SECTION 14: TRANSPORT INFORMATION
Must be shippied in accordance with all applicable Local, State and Federal Regulations. Processing, use or contamination of this kit or its
components may change shipping requirements and options. As offered for shipping (based on single kit only).
UN Proper Shipping Name: Not applicable.
UN Number: Not applicable.
Packing Group: Not applicable.
Marine Pollutant: Not available.
Hazardous Substance Reportable Quantity: Not available.
Special Provisions for Transport: Not applicable.
DOT Classification for Bulk Shipments: Not a dangerous good. Not a DOT controlled material (United States).
TDG Classification: Not a dangerous good. Not controlled under TDG.
ADR/RID Classification: Not a dangerous good. Not controlled under ADR (Europe)
IMO/IMDG Classification: Not a dangerous good. Not Controlled under IMDG.
ICAO/IATA Classification: Not a dangerous good. Not controlled under IATA.
SECTION 15: REGULATORY INFORMATION
TSCA inventory: Most components are listed as commercial status active on the TSCA.
SARA 301/302/303: No chemicals in this product are listed as extremely hazards substances in 40 CFR 355, Emergency
Planning and Notification (Appendix A to Part 355).
WHMIS: Not controlled under WHMIS.
California Prop.65: There are no Proposition 65 chemicals present in this products levels that would require a warning
under the California Safe Drinking Water and Toxic Enforcement Act.
REACH Regulation List of Substances of very high concern (SVHC): None of the ingredients is listed according to regulation (EC) No 1907/2006 and
according to regulation (EU) 2021/2030.
Chemical safety assessment: A Chemical Safety Assessment has not been carried out.
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MATERIAL SAFETY DATA SHEET
SECTION 16: OTHER INFORMATION
The contents and format of this MSDS are in accordance with ISO Commission Directive ISO11014:2009.
DISCLAIMER OF LIABILITY
The information in this MSDS was obtained from sources which we believe are reliable. However, the information is
provided without any warranty, express or implied, regarding its correctness. The conditions or methods of handling, storage,
use or disposal of the product are beyond our control and may be beyond our knowledge. For this and other reasons, we
do not assume responsibility and expressly disclaim liability for loss, damage or expense arising out of or in any way
connected with the handling, storage, use or disposal of the product. This MSDS was prepared and is to be used only for
this product. If the product is used as a component in another product, this MSDS information may not be applicable.
Abbreviations and acronyms:
NFPA: National Fluid Power Association.
GHS: Globally Harmonized System of Classification and Labelling of Chemicals.
CLP: Classification, labeling and packaging.
NTP: National Toxicology Program.
OSHA: Occupational safety and health administration.
IARC: International Agency for Research on Cancer.
PBT: Persistent, Bioaccumulative and Toxic.
vPvB: very Persistent and very Bioaccumulative.
CAS: Chemical Abstracts Service (division of the American Chemical Society).
LC50: Lethal concentration, 50 percent.
LD50: Lethal dose, 50 percent.
DOT: U.S. Department of Transportation.
TDG: Transportation of Dangerous Goods Program.
ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the
International Carriage of Dangerous Goods by Road).
RID: Règlement international concernant le transport des marchandises dangereuses par chemin de fer (Regulations
Concerning theInternational Transport of Dangerous Goods by Rail).
IMO: International Maritime Organization.
IMDG: International Maritime Code for Dangerous Goods.
IATA: International Air Transport Association.
ICAO: International Civil Aviation Organization.
TSCA: Toxic Substances Control Act.
WHMIS: Workplace Hazardous Materials Information System
To the best of our knowledge, the information contained herein is accurate. However, neither the above named supplier
nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the information contained
herein. Final determination of suitability of any material is the sole responsibility of the user. All materials may present
unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee
that these are the only hazards that exist.
Version:GP202404
CK Reagent Kit (Phosphocreatine Substrate method) 6/6 Date: 2024/04/01
