CMV BRITE ANTIGENEMIA TEST KIT

CMV BRITE ANTIGENEMIA TEST KIT is an FDA 510(k)-cleared medical device (K951550) manufactured by Biotest Diagnostics 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 January 29, 1996. Regulation: 8.