CYTOMEGALOVIRUS ANTIBODY SCREEN

CYTOMEGALOVIRUS ANTIBODY SCREEN is an FDA 510(k)-cleared medical device (K910003) manufactured by Immucor, 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 March 19, 1991. Regulation: 8.