JBAIDS TULAREMIA DETECTION KIT

JBAIDS TULAREMIA DETECTION KIT is an FDA 510(k)-cleared medical device (K131936) manufactured by Biofire Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 30, 2013. Regulation: 8.