
Biosite Incorporated
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ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP is an FDA 510(k)-cleared medical device (K092048) manufactured by Biosite Incorporated. 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 18, 2010. Regulation: 8.