NEIA TRANSFERRIN ENZYMEIMMUNOASSAY

NEIA TRANSFERRIN ENZYMEIMMUNOASSAY is an FDA 510(k)-cleared medical device (K813288) manufactured by New England Immunology Assoc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 1981. Regulation: 8.