CAPTIA SYPHILIS-G ELISA TEST SYSTEM

CAPTIA SYPHILIS-G ELISA TEST SYSTEM is an FDA 510(k)-cleared medical device (K001525) manufactured by Trinity Biotech, Plc. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 2000. Regulation: 8.