BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM

BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM is an FDA 510(k)-cleared medical device (K991185) manufactured by Zeus Scientific, 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 September 2, 1999. Regulation: 8.