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Biofire Diagnostics, LLC
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FilmArray Meningitis/Encephalitis(ME) Panel is an FDA 510(k)-cleared medical device (DEN150013) manufactured by Biofire Diagnostics, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 7, 2015. Regulation: 8.