BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST

BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST is an FDA 510(k)-cleared medical device (K911145) 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 May 9, 1991. Regulation: 8.