CYTOMEGALOVIRUS (CMV) ELISA

CYTOMEGALOVIRUS (CMV) ELISA is an FDA 510(k)-cleared medical device (K904456) manufactured by Virotech, 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 April 2, 1991. Regulation: 8.