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Enzyme Immunoassay, Cocaine And Cocaine Metabolites

FDA product code DIO · Class 2 · Clinical Toxicology

4,680
Registered devices
74
Adverse events
23
Recalls
145
510(k) clearances

Devices with this code

INCUP — AMERICAN BIO MEDICA CORPORATIONEasy@Home Multi-Drug Screen Test (5 tests kit) — EASY HEALTHCARE CORPORATIONToxCup Drug Screen Cup — BRANAN MEDICAL CORPORATIONToxCup Drug Screen Cup — BRANAN MEDICAL CORPORATIONSTATCUP® — MICRO DISTRIBUTING, L.CPROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.RDS — AMERICAN BIO MEDICA CORPORATIONRTCII 1st gen. — AMERICAN BIO MEDICA CORPORATIONAreta Multi-Drug Test Cup (5 tests kit) — EASY HEALTHCARE 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.Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INCDrugCheck — Express Diagnostic Int'l, Inc.DrugCheck — Express Diagnostic Int'l, Inc.Easy@Home Multi-Drug Test Cup (5 tests kit) — EASY HEALTHCARE CORPORATIONUCP — UCP BIOSCIENCES, INC.INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, THC — ALFA SCIENTIFIC DESIGNS, INC.UCP Home Drug Screening Test Cups — MEDICAL DISTRIBUTION GROUP INCProScreen — Instant Technologies, Inc.NA — Alere San Diego, Inc.DrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.

Recent recalls

DateFirmReason
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels sta
2017-12-20OraSure Technologies, Inc.The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
2016-07-05Branan Medical CorporationBranan Medical is recalling the AmediCheck Instant Test Cup, a 5 panel drug cup, because it may erroneously contain 12 panel cups due to a packaging error.

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