Dx Focus: FDA Clears Quidel Flu, RSV, hMPV Assays; Unilabs to Market Diagnoplex's Colox Test | GenomeWeb

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.

The Quidel Molecular Influenza A+B assay detects influenza A and/or B virus, but does not differentiate influenza A subtypes. However, the assay is able to detect subtype H7N9, which has caused more than one hundred infections to date in China, with a mortality rate of approximately 30 percent.

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