MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY

MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY is an FDA 510(k)-cleared medical device (K982027) 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 November 24, 1998. Regulation: 8.