QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT

QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K842692) manufactured by Quidel Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 4, 1984. Regulation: 8.