FDA-cleared assays for molecular diagnostics

Find in vitro diagnostic kits to support cystic fibrosis testing and IVD assay development on the MiSeqDx System

MiSeqDx Products & Services

TruSight Cystic Fibrosis
TruSight Cystic Fibrosis

FDA-cleared, CE-IVD-marked next-generation sequencing test that conveniently provides two cystic fibrosis testing assays in one product.

TruSeq Custom Amplicon Kit Dx
TruSeq Custom Amplicon Kit Dx

A validated, FDA-regulated and CE-IVD-marked kit enabling clinical laboratories to design their own next-generation sequencing assays for use on the MiSeqDx and NextSeq 550Dx systems.

MiSeqDx Reagent Kit v3
MiSeqDx Reagent Kit v3

A validated, FDA-regulated, CE-IVD–marked sequencing kit for use on the MiSeqDx instrument, offering improved quality scores compared to previous versions.


Comprehensive Scientific Support

Illumina services and support begins when the MiSeqDx System is delivered. Illumina scientists and engineers assist with NGS system installation and setup and train laboratory personnel. In addition to on-site support, training courses are available to bring laboratory personnel quickly up to speed.

Illumina scientists are available 24/7 globally to answer questions every step of the way, enabling researchers to focus on making the next breakthrough discovery.


Illumina Qualification Services

We offer comprehensive qualification services to help labs meet compliance requirements.

Illumina University

Get high-quality results on Illumina technology even faster with instructor-led, hands-on courses and web-based training options.

Illumina Consulting

Illumina provides consulting services that connect an experienced Illumina team direct to the laboratory to jump-start successful sequencing workflow implementation.