BioMérieux's BioFire Unit Submits Meningitis/Encephalitis Panel for FDA Clearance | GenomeWeb

NEW YORK (GenomeWeb) – BioMérieux said today that its BioFire subsidiary has submitted a de novo classification request to the US Food and Drug Administration for the FilmArray Meningitis/Encephalitis (ME) panel.

FilmArray ME tests cerebrospinal fluid for the most common bacteria, viruses, and fungi responsible for community-acquired meningitis or encephalitis. The panel takes about an hour to run on BioFire's FilmArray molecular testing platform, a fully automated system that combines highly multiplexed PCR and melt curve analysis.

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