Solution reagent kit MiSeqDx

diagnosticGMP

A validated, FDA-regulated, CE-marked IVD sequencing reagent kit, offering improved quality scores compared to previous versions. Overview The MiSeqDx Reagent Kit v3 contains a single-use set of reagents and consumables for sequencing libraries prepared for validated assays. To help labs meet quality requirements and ensure operational stability in a regulated environment, the kit offers: Single-lot shipments Integrated component and kit lot testing Certificates of analysis Advance change notifications Improved sequencing by synthesis (SBS) chemistry The MiSeqDx Reagent Kit v3 delivers higher cluster densities, read lengths, and quality scores compared to previous versions. Regulatory compliance The MiSeqDx Reagent Kit v3 is an FDA-regulated Class I and CE-marked in vitro diagnostic (IVD) sequencing kit issued with a certificate of analysis, which labs can use to satisfy regulatory qualification activities. Minimal revalidation Single-lot shipments reduce the potential for variability between lots, minimize revalidation costs, improve traceability, and support lab tracking needs. Quality assurance The kit is manufactured under Good Manufacturing Practice (GMP) regulations and undergoes both individual component and kit lot testing to ensure high quality. 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. Specifications Assay time - 28 hr Hands-on time - 10 min