FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS

FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS is an FDA 510(k)-cleared medical device (K791948) manufactured by Intl. Diagnostic Technology. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 15, 1979. Regulation: 8.