BioFire Blood Culture Identification 2 (BCID2) Panel

BioFire Blood Culture Identification 2 (BCID2) Panel is an FDA 510(k)-cleared medical device (K193519) 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 17, 2020. Regulation: 8.