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Guangzhou Wondfo Biotech Co., Ltd.
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ACON BUP ONE STEP BUPRENORPHINE TEST STRIP is an FDA 510(k)-cleared medical device (K130055) manufactured by Guangzhou Wondfo Biotech Co., Ltd.. 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 February 13, 2013. Regulation: 8.