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Biofire Diagnostics, LLC
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FilmArray Respiratory Panel 2 plus (RP2plus) is an FDA 510(k)-cleared medical device (DEN170017) manufactured by Biofire Diagnostics, LLC. This device is classified under the Pathology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 23, 2017. Regulation: 8.