MiSeqDx Reagent Kit v3

A validated, FDA-regulated, CE-marked IVD sequencing reagent kit, offering improved quality scores compared to previous versions.

This product is only available in select locations. Please select the location where you would like this product to be shipped to see availability.


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. 


Required products

Intended for use with the MiSeqDx Instrument. Requires use of a validated library preparation solution.  
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The MiSeqDx Reagent Kit v3 is used by clinical laboratories for in vitro diagnostic testing and assay development on the MiSeqDx Instrument. 

Example workflow

Related applications and methods


MiSeqDx Reagent Kit v3 performance parameters*

Read length No. of reads passing filter Bases > Q30 Maximum output Total overall accuracy Total overall reproducibility
2 × 150 bp > 15 million ≥ 80% > 5 Gb ≥ 99.66% ≥ 99.70%


*See the MiSeqDx Instrument specification sheet for minimum run requirements needed to achieve desired accuracy and reproducibility levels.

MiSeq Dx Reagent Kit v3


Includes one flow cell and one prefilled cartridge containing clustering and sequencing reagents to support one run of sample libraries on the MiSeqDx System.

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The MiSeqDx Reagent Kit v3 is validated for use with TruSight Cystic Fibrosis. The MiSeqDx Reagent Kit v3 is a required product for these assays and is sold separately.

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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