
Quidel Corp.
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CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO is an FDA 510(k)-cleared medical device (K973858) 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 25, 1997. Regulation: 8.