COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY

COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY is an FDA 510(k)-cleared medical device (K992552) manufactured by DiaSorin, 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 December 15, 1999. Regulation: 8.