QUANTIMUNE(R) FERRITIN IRMA

QUANTIMUNE(R) FERRITIN IRMA is an FDA 510(k)-cleared medical device (K863487) manufactured by Bio-Rad. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 30, 1986. Regulation: 8.