Quidel gets another FDA 501(k) nod for flu, RSV/ hMPV assays

The FDA grants 501(k) clearance for Quidel's (QDEL) Molecular Influenza A+B assay and Molecular RSV + hMPV assay for use on Life Technologies' (LIFE) QuantStudio" Dx Real-Time PCR Instrument.

Notable: The Molecular Influenza A+B assay can detect the H7N9 subtype. (PR)

These assays are also cleared for use with Cepheid's (CPHD) SmartCycler II.

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