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Biofire Diagnostics, LLC
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BioFire Respiratory Panel 2.1 (RP2.1) is an FDA 510(k)-cleared medical device (DEN200031) 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 March 16, 2021. Regulation: 8.