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Enzyme Immunoassay, Cocaine And Cocaine Metabolites

FDA product code DIO · Class 2 · Clinical Toxicology

0
Registered devices
75
Adverse events
23
Recalls
145
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 INCPreview — WONDFO USA CO., LTD.INSTA-SCREEN-2TM Cup — NOBLE MEDICAL INCAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.reditest® — REDWOOD TOXICOLOGY LABORATORY, INC.QuickProfile™ Drugs of Abuse Panel 7 Test — LUMIQUICK DIAGNOSTICS, INC.Alere iScreen Dx — Instant Technologies, Inc.INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, THC, XTC — ALFA SCIENTIFIC DESIGNS, INC.BluRapids™ — MERCEDES MEDICAL, LLCDrugSmart Cup 13 — CHEMTRON BIOTECH INCSTATCUP® II — MICRO DISTRIBUTING, L.CHealgen — Healgen Scientific Limited Liability CompanyDrugSmart Cup — CHEMTRON BIOTECH INCFastect II Drug Screen Dipstick Test — BRANAN MEDICAL CORPORATIONHigh Sensitivity — Alere San Diego, Inc.Advin Multi-Drug Screen Test — ADVIN BIOTECH, INC.NOBLE — NOBLE MEDICAL INCQuickTox Drug Screen Dipcard — AMEDITECH INC.INCUP — AMERICAN BIO MEDICA CORPORATIONDrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.Advin Multi-Drug Screen Test — ADVIN BIOTECH, 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.