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Biofire Diagnostics, Inc.
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FILMARRAY RESPIRATORY PANEL (RP) is an FDA 510(k)-cleared medical device (K123620) manufactured by Biofire Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 10, 2013. Regulation: 8.