QUIDEL HCG ENZYME IMMUNOASSAY KIT

QUIDEL HCG ENZYME IMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K833156) 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 November 24, 1983. Regulation: 8.