FDA Device Intelligence
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Enzyme Immunoassay, Barbiturate

FDA product code DIS · Class 2 · Clinical Toxicology

2,562
Registered devices
5
Adverse events
7
Recalls
100
510(k) clearances

Devices with this code

ToxCup Drug Screen Cup — BRANAN MEDICAL CORPORATIONToxCup Drug Screen Cup — BRANAN MEDICAL CORPORATIONSTATCUP® — MICRO DISTRIBUTING, L.CSTATDIP® — MICRO DISTRIBUTING, L.CPROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.RDS — AMERICAN BIO MEDICA CORPORATIONU-Screen — Instant Tech Subsidiary AcquisitionRTCII 2nd gen. — AMERICAN BIO MEDICA CORPORATIONPremier Bio-Cup & Bio-Dip — PREMIER BIOTECH, INCDrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.DrugSmart Cup — Twin Spirit Inc.Easy@Home Multi-Drug Test Cup (5 tests kit) — EASY HEALTHCARE CORPORATIONUCP — UCP BIOSCIENCES, INC.UCP Home Drug Screening Test Cups — MEDICAL DISTRIBUTION GROUP INCProScreen — Instant Technologies, Inc.DrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.DrugCheck — Express Diagnostic Int'l, Inc.DrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.Speedy Tests — SPEEDY SOLUTIONS LLCiCup® — Instant Technologies, Inc.DrugCheck — Express Diagnostic Int'l, Inc.Twelve Panel PreScreen Plus Cup With Adulterants (CLIA Waived) — MERGERS MARKETING, INC.ECO™ Cup — W.H.P.M. INC.

Recent recalls

DateFirmReason
2019-06-12Beckman Coulter Inc.The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The prese
2018-05-18Guangzhou Wondfo Biotech Co., Ltd.GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use o
2018-05-18Guangzhou Wondfo Biotech Co., Ltd.GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use o
2018-05-18Guangzhou Wondfo Biotech Co., Ltd.GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use o
2016-11-10OraSure Technologies, Inc.Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
2012-01-04Alere San DiegoAlere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA.
2011-09-08Lin-Zhi International IncCatalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not hav

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.