Products for in vitro diagnostic use

In Vitro Diagnostic (IVD) Products

Systems
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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.

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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.

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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.