BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini

BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini is an FDA 510(k)-cleared medical device (K243544) 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 August 13, 2025. Regulation: 8.