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Enzyme Immunoassay, Barbiturate

FDA product code DIS · Class 2 · Clinical Toxicology

0
Registered devices
5
Adverse events
7
Recalls
100
510(k) clearances

Devices with this code

Syva® RapidTest d.a.u.® 10 — Siemens Healthcare Diagnostics Inc.Healgen — Healgen Scientific Limited Liability CompanyT-Cup — WONDFO USA CO., LTD.NOBLE — NOBLE MEDICAL INCAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.reditest® — REDWOOD TOXICOLOGY LABORATORY, INC.Alere iScreen Dx — Instant Technologies, Inc.BluRapids™ — MERCEDES MEDICAL, LLCDrugSmart Cup 13 — CHEMTRON BIOTECH INCHealgen — Healgen Scientific Limited Liability CompanyDrugSmart Cup — CHEMTRON BIOTECH INCAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.NOBLE — NOBLE MEDICAL INCDrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.Advin Multi-Drug Screen Test — ADVIN BIOTECH, INC.Advin Multi-Drug Screen Test with SVT — ADVIN BIOTECH, INC.DrugCheck — Express Diagnostic Int'l, Inc.QuickTox Drug Screen Dipcard — BRANAN MEDICAL CORPORATIONAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.Healgen — Healgen Scientific Limited Liability CompanyDrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.DrugCheck — Express Diagnostic Int'l, Inc.CLIAwaived — Cliawaived, Inc.Healgen — Healgen Scientific Limited Liability Company

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.