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NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted 510(k) clearance and CLIA waiver to a respiratory panel from BioMérieux's molecular biology affiliate BioFire Diagnostics, the firm announced today. The test will be available in the US only and is expected to launch in November of 2016.

The FilmArray Respiratory Panel EZ runs in approximately one hour on the FilmArray platform and detects 11 viruses and three bacterial pathogens from nasopharyngeal swabs, requiring two minutes of hands-on time.

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