The MiSeqDx System is the first FDA-cleared platform for in vitro diagnostic (IVD) testing. It features a growing menu of assays and kits that enables clinical laboratories to create and deploy next-generation sequencing-based molecular diagnostic testing for an expanding list of applications.
Have questions about the MiSeqDX? Get Questions Answered »
Learn how the MiSeqDx System delivers the power of FDA-cleared next-generation sequencing into your laboratory.
The MiSeqDx System has the following exterior components:
The MiSeqDx interface guides users through the run setup steps using the touch screen monitor.
Find out how the MiSeq series enables a range of workflows with simplicity, speed, and exceptional accuracy for your clinical and research needs.
|Regulatory Status||FDA Cleared
|For Research Use Only.
Not for use in diagnostic procedures.
|IVD Assay Menu||Cystic Fibrosis 139-Variant Assay
Cystic Fibrosis Clinical Sequencing Assay
Future Illumina Assays
Future Partner Assays
|Universal Kit||Universal Kit V1.0
(FDA cleared library prep and sequencing reagents for the creation of LDTs)
|RUO Applications||Same as MiSeq||Desktop sequencing for a variety of applications|
|System Software||Fully integrated ecosystem including on instrument data analysis. Software partitioned for IVD and Research applications.||Fully integrated ecosystem including on instrument data analysis. IVD applications not available.|
Contact an Illumina representative for regional availability.