
Quidel Corp.
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POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN is an FDA 510(k)-cleared medical device (K905176) manufactured by Quidel 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 December 12, 1990. Regulation: 8.