BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM

BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM is an FDA 510(k)-cleared medical device (K033070) manufactured by Trinity Biotech USA. 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 25, 2003. Regulation: 8.