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Thermo Fisher Scientific
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DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS is an FDA 510(k)-cleared medical device (K081378) manufactured by Thermo Fisher Scientific. 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 January 13, 2009. Regulation: 8.