HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS

HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS is an FDA 510(k)-cleared medical device (K920222) manufactured by Akers Research Corp.. 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 26, 1992. Regulation: 8.