BIOFIRE FILMARRAY Tropical Fever Panel

BIOFIRE FILMARRAY Tropical Fever Panel is an FDA 510(k)-cleared medical device (K243463) manufactured by Biofire Diagnostics, LLC (Biomerieux). This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2024. Regulation: 8.