CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST)

CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) is an FDA 510(k)-cleared medical device (K893467) manufactured by Immuno Concepts, 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 13, 1989. Regulation: 8.