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:
Integrated component and kit lot testing
Certificates of Analysis (CofA)
Advance change notifications
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.
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.
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.