AFFINITY(TM) FERRITIN IMMUNIT(TM)

AFFINITY(TM) FERRITIN IMMUNIT(TM) is an FDA 510(k)-cleared medical device (K885074) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 3, 1989. Regulation: 8.