HYBRID CAPTURE SYSTEM CMV DNA ASSAY

HYBRID CAPTURE SYSTEM CMV DNA ASSAY is an FDA 510(k)-cleared medical device (K974901) manufactured by Digene 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 September 28, 1998. Regulation: 8.