CYTOMEGALO VIRUS & CONTROLS

CYTOMEGALO VIRUS & CONTROLS is an FDA 510(k)-cleared medical device (K802930) manufactured by Orion Diagnostica, 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 January 8, 1981. Regulation: 8.