FIAX HAPTOGLOBIN TEST KIT

FIAX HAPTOGLOBIN TEST KIT is an FDA 510(k)-cleared medical device (K843570) 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 October 4, 1984. Regulation: 8.