FDA Clears Quest's Respiratory Virus Molecular Test | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing a molecular respiratory virus test made by Quest Diagnostics' Focus Diagnostics business, the firm said today.

The agency granted 510(k) clearance for the Focus Diagnostics Simplexa Flu A/B & RSV test for use on the 3M Integrated Cycler. The Simplexa RT-PCR test is intended to aid in the detection and discrimination of influenza A, influenza B, and respiratory syncytial virus infections.

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