FIAX RHEUMATOID FACTOR TEST KIT

FIAX RHEUMATOID FACTOR TEST KIT is an FDA 510(k)-cleared medical device (K812968) manufactured by Intl. Diagnostic Technology. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 5, 1981. Regulation: 8.