COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV

COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV is an FDA 510(k)-cleared medical device (K875367) 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 March 27, 1988. Regulation: 8.