BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM

BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM is an FDA 510(k)-cleared medical device (K885294) manufactured by Medical Diagnostic Technologies, 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 April 9, 1989. Regulation: 8.