PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY

PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY is an FDA 510(k)-cleared medical device (K981913) manufactured by Chembio Diagnostic Systems, 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 February 11, 1999. Regulation: 8.