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Branan Medical Corporation
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ORATECT ORAL FLUID DRUG SCREEN DEVICES is an FDA 510(k)-cleared medical device (K103227) manufactured by Branan Medical Corporation. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 10, 2012. Regulation: 8.