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human metapneumovirus

The US Food and Drug Administration has granted 510(k) clearance to Quidel's Molecular Influenza A+B and RSV+hMPV assays for use on Life Technologies' QuantStudio Dx real-time PCR instrument, the companies said this week.

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has granted 510(k) clearance to Quidel's Molecular Influenza A+B and RSV+hMPV assays for use on Life Technologies' QuantStudio Dx Real-Time PCR instrument, the companies said today.

Quidel said this week that it has received 510(k) clearance from the US Food and Drug Administration for its Quidel Molecular RSV + hMPV assay for the detection of respiratory syncytial virus and human metapneumovirus.

NEW YORK (GenomeWeb News) – Quidel has received US Food and Drug Administration 510(k) clearance to market its molecular respiratory viral panel in the US, the company said on Tuesday.

Enzo Biochem said this week that it has filed an application with New York State for approval of its first assay based on its new AmpiProbe nucleic acid detection technology.

Quidel this week provided an update on its budding molecular diagnostics business, noting that it saw "significant progress" in each of its three MDx initiatives.

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.

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Life Technologies will distribute and sell Quidel's molecular diagnostic assays in Europe under an agreement announced today.

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