
Biofire Diagnostics, LLC
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BioFire Joint Infection (JI) Panel is an FDA 510(k)-cleared medical device (DEN200066) 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 April 28, 2022. Regulation: 8.