SYPHILIS BIO-ENZABEAD KIT

SYPHILIS BIO-ENZABEAD KIT is an FDA 510(k)-cleared medical device (K820934) manufactured by Biometics Laboratory Products. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 9, 1982. Regulation: 8.