THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST

THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST is an FDA 510(k)-cleared medical device (K000687) manufactured by Beacon Biologicals, 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 June 11, 2000. Regulation: 8.