FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD

FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD is an FDA 510(k)-cleared medical device (K792249) 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 January 22, 1980. Regulation: 8.