
Biochemical Diagnostics, Inc.
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Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series is an FDA 510(k)-cleared medical device (K153474) manufactured by Biochemical Diagnostics, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 22, 2016. Regulation: 8.