TINA-QUANT FERRITIN ASSAY

TINA-QUANT FERRITIN ASSAY is an FDA 510(k)-cleared medical device (K964282) manufactured by Boehringer Mannheim Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 1997. Regulation: 8.