Focused diagnostic power

Leverage the proven power of the MiSeq System in your clinical laboratory

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.

See more MiSeqDx Applications here.

Have questions about the MiSeqDX? Get Questions Answered »

Discover the MiSeqDx System

Learn how the MiSeqDx System delivers the power of FDA-cleared next-generation sequencing into your laboratory.

System details »
Quick preview »

The MiSeqDx System has the following exterior components:

  1. Flow cell compartment: Contains the flow cell stage that houses the flow cell throughout the run. Flow cell stage motors move the stage of the enclosed optical module for flow cell loading and returns the stage when the run begins.
  2. Enclosed optics module: Contains optical components that enable imaging of the flow cell.
  3. Status bar: Uses three colors to indicate instrument status. Blue indicates that the instrument is processing, orange indicates the instrument needs attention, and green indicates that the instrument is ready to begin the next run.
  4. Touch screen monitor: Enables on-instrument configuration and run setup using the software interface.
  5. External USB port: Facilitates the transfer of files and data to the instrument computer from the touch screen monitor.
  6. Reagent compartment: Holds reagents at proper temperatures, wash solutions, and the waste bottle. A magnetic latch secures the reagent compartment door.

The MiSeqDx interface guides users through the run setup steps using the touch screen monitor.

Compare MiSeq Series Capabilities

Find out how the MiSeq series enables a range of workflows with simplicity, speed, and exceptional accuracy for your clinical and research needs.

Comparison chart »

System MiSeqDx System


MiSeq System


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
Not Available
Universal Kit Universal Kit V1.0
(FDA cleared library prep and sequencing reagents for the creation of LDTs)
Not Available
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.

Evaluate the MiSeqDx System

Learn more about the MiSeqDx System and its capabilities.

Specification sheet »
Specifications »

Choose Your Clinical IVD Application

Select from an ever-expanding menu of FDA-cleared assays available exclusively on the MiSeqDx System.

Cystic fibrosis »
Lab-developed tests »

For In Vitro Diagnostic Use.

Contact an Illumina representative for regional availability.