Illumina Receives FDA Clearance for MiSeqDx, Cystic Fibrosis Assays | GenomeWeb

NEW YORK (GenomeWeb News) – Illumina said today that it has received premarket clearance from the US Food and Drug Administration for its MiSeqDx system, two cystic fibrosis assays, and a library prep kit that enables laboratories to develop their own diagnostic tests.

The designation marks the first time a next-generation sequencing system has received FDA premarket clearance.

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