Quidel Receives Its First FDA Clearance for MDx Assays | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Quidel announced on Friday that the US Food and Drug Administration has cleared for marketing two of its molecular tests, one for human metapneumovirus and the other for influenza A and B, making them the San Diego company's first FDA-cleared MDx tests.

The Quidel Molecular hMPV Assay is the first molecular test from the company to receive FDA 510(k) clearance, it said, adding it was launched in Europe after getting CE marked in September 2011.

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