Description
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.
For In Vitro Diagnostic Use
Contact an Illumina representative for regional availability.
Applications
The MiSeqDx Reagent Kit v3 is used by clinical laboratories for in vitro diagnostic testing and assay development on the MiSeqDx Instrument.
Example workflow
TruSight Cystic Fibrosis
Illumina DNA Prep with Enrichment Dx
Related applications and methods
IVD assay development
Develop your own IVD assays on the MiSeqDx Instrument.
Molecular diagnostics
Illumina offers next-generation sequencing-based molecular diagnostic options for clinical laboratories.
MiSeqDx Reagent Kit v3 performance parameters*
Read length: No. of reads passing filter
2 × 150 bp: > 15 million
*See the MiSeqDx Instrument specification sheet for minimum run requirements needed to achieve desired accuracy and reproducibility levels.
MiSeq Dx Reagent Kit v3
20037124
Includes one flow cell and one prefilled cartridge containing clustering and sequencing reagents to support one run of sample libraries on the MiSeqDx System. View less
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What is the difference between the MiSeqDx Instrument and the MiSeq System?
The MiSeqDx Instrument is FDA-regulated and CE-marked and provides both diagnostic and research modes. The MiSeq System is for research use only. In vitro diagnostic (IVD) testing is only supported on the MiSeqDx Instrument.
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