BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN

BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN is an FDA 510(k)-cleared medical device (K904036) manufactured by Baxter Healthcare 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 October 15, 1990. Regulation: 8.