COPALIS CMV TOTAL ANTIBODY ASSAY

COPALIS CMV TOTAL ANTIBODY ASSAY is an FDA 510(k)-cleared medical device (K955799) manufactured by Sienna Biotech, 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 July 9, 1996. Regulation: 8.