IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI

IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI is an FDA 510(k)-cleared medical device (K871246) 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 August 24, 1987. Regulation: 8.