BARTELS CINAKIT CMV ANTIGENEMIA

BARTELS CINAKIT CMV ANTIGENEMIA is an FDA 510(k)-cleared medical device (K982311) manufactured by Intracel 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 December 13, 1998. Regulation: 8.