CMV BRITE TURBO KIT

CMV BRITE TURBO KIT is an FDA 510(k)-cleared medical device (K991650) 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 July 11, 1999. Regulation: 8.