The MiSeqDx instrument is the first and only FDA-cleared in vitro diagnostic (IVD) next-generation sequencing (NGS) system. Designed specifically for the clinical laboratory environment, the MiSeqDx instrument offers a small, approximately 4 square feet (0.3 square meters) footprint, an easy-to-follow workflow, and data output tailored to the needs of clinical labs. In addition, the integrated software enables sample tracking, user traceability, and results interpretation*. Taking advantage of proven Illumina sequencing by synthesis (SBS) chemistry, the MiSeqDx instrument provides accurate, reliable screening, and diagnostic testing.
Currently, three ready-to-use FDA-cleared tests are available;
1.MiSeqDx Universal Kit
Develop your own diagnostic tests
2.MiSeqDx Cystic Fibrosis 139-Variant Assay
The largest panel (139) of clinically relevant, functionally validated variants for cystic fibrosis.
3.MiSeqDx Cystic Fibrosis 139-Variant Assay
IVD NGS test providing a comprehensive view of the CFTR gene
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