COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION

COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION is an FDA 510(k)-cleared medical device (K872576) manufactured by Enzo Biochem, 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 December 3, 1987. Regulation: 8.