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


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.

Second, Quidel received FDA marketing clearance for its Molecular Influenza A+B Assay for detecting influenzas A and B. Quidel also launched this product in Europe after receiving the CE Mark in August.

Both assays are part of the Quidel Molecular product line, which consists of PCR reagent kits for use by molecular diagnostic laboratories using Life Technologies' Applied Biosystems 7500 Fast Dx thermocycler. The reagents include features for simple transport and storage, convenient workflow, and a short time to result, among other benefits, Quidel said.