
OraSure Technologies, Inc.
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INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX is an FDA 510(k)-cleared medical device (K011057) manufactured by OraSure Technologies, Inc.. 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 June 5, 2001. Regulation: 8.