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

MiSeqDx Cystic Fibrosis 139-Variant Assay
MiSeqDx Cystic Fibrosis 139-Variant Assay

FDA-cleared NGS assay with the largest panel of clinically relevant, functionally validated cystic fibrosis variants in a diverse population.

MiSeqDx Cystic Fibrosis Clinical Sequencing Assay
MiSeqDx Cystic Fibrosis Clinical Sequencing Assay

FDA-cleared next-generation sequencing assay provides a full view of coding regions of the CFTR gene, to aid in in vitro diagnosis of cystic fibrosis.

MiSeqDx Universal Kit
MiSeqDx Universal Kit

A validated, FDA-cleared kit that enables molecular diagnostic laboratories to design their own next-generation sequencing assays for use on the MiSeqDx System.


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 Product Care

In addition to the 1-year basic service warranty included with system purchase, Illumina offers maintenance, repair, and qualification solutions.

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.