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Becton, Dickinson & CO
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BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY is an FDA 510(k)-cleared medical device (K130268) manufactured by Becton, Dickinson & CO. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 2013. Regulation: 8.