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Enzyme Immunoassay, Cannabinoids

FDA product code LDJ · Class 2 · Clinical Toxicology

0
Registered devices
3
Adverse events
15
Recalls
150
510(k) clearances

Devices with this code

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.BluRapids™ — MERCEDES MEDICAL, LLCMD DugScreen — Medical Disposables CorpDrugSmart Cup 13 — CHEMTRON BIOTECH INCHealgen — 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.AllSource Screening Solutions - Drug Detector — ALLSOURCE SCREENING SOLUTIONS, LLCDrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.Advin Multi-Drug Screen Test — ADVIN BIOTECH, INC.Advin Multi-Drug Screen Test with SVT — ADVIN BIOTECH, INC.QuickTox Drug Screen Dipcard — BRANAN MEDICAL CORPORATION

Recent recalls

DateFirmReason
2023-10-04Family Dollar Stores, Llc.Products were stored outside of labeled temperature requirements.
2022-06-23Family Dollar Stores, Llc.Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
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 IncXXX
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
2020-02-10Carolina Liquid Chemistries CorpCorrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only.

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