Solution reagent kit MiSeq Dx

diagnosticfor DNA sequencingGMP

The MiSeqDx Reagent Kit v3 features improved sequencing by synthesis (SBS) chemistry, resulting in higher cluster densities, read lengths, and quality scores compared to previous versions. To help labs meet quality requirements and ensure operational stability in a regulated environment, these kits offer: Single-lot shipments Integrated component and kit lot testing Certificates of Analysis (CofA) Advance change notifications Regulatory Compliance The MiSeqDx Reagent Kit v3 is an FDA-regulated Class I and CE-IVD–marked sequencing kit. It is issued with a Certificate of Analysis (CofA), which labs can use to satisfy regulatory qualification activities. Minimal Revalidation To reduce the potential for variability between lots and minimize revalidation costs, the MiSeqDx Reagent Kit v3 is delivered in single-lot shipments. Single-lot deliveries also improve traceability and support lab tracking needs. Quality Assurance The MiSeqDx Reagent Kit v3 is manufactured under Good Manufacturing Practice (GMP) regulations and undergoes both individual component and kit lot testing to ensure high quality. This integrated testing evaluates how the components of a kit perform individually and together as one unit. Operational Stability To ensure high operational stability, Illumina provides advance change notifications before making any significant changes to the reagents. Intended Use The Illumina MiSeqDx Reagent Kit v3 is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The MiSeqDx Reagent Kit v3 is intended for use with the MiSeqDx instrument and analytical software.