CMV-VUE(TM) CMV ANTIGEN DETECTION KIT

CMV-VUE(TM) CMV ANTIGEN DETECTION KIT is an FDA 510(k)-cleared medical device (K921616) manufactured by Incstar 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 August 10, 1992. Regulation: 8.