Dx Focus: Quidel Gets FDA OK for First Pair of Molecular Tests | GenomeWeb

Quidel in December received 510(k) clearance from the US Food and Drug Administration for two molecular diagnostic tests, the company's first two molecular tests to receive such approval.

First, Quidel received 510(k) clearance for the Quidel Molecular hMPV Assay for detecting human metapneumovirus. Quidel received the CE Mark for the assay in September.

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