TREPCHEK TREPONEMAL ANTIBODY EIA

TREPCHEK TREPONEMAL ANTIBODY EIA is an FDA 510(k)-cleared medical device (K001552) manufactured by Phoenix Biotech Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 2000. Regulation: 8.