FDA Device Intelligence
Home › Device types › LDJ

Enzyme Immunoassay, Cannabinoids

FDA product code LDJ · Class 2 · Clinical Toxicology

4,047
Registered devices
2
Adverse events
15
Recalls
150
510(k) clearances

Devices with this code

Easy@Home Multi-Drug Screen Test (5 tests kit) — EASY HEALTHCARE CORPORATIONToxCup Drug Screen Cup — BRANAN MEDICAL CORPORATIONPROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.RDS — AMERICAN BIO MEDICA CORPORATIONDOA 3 PANEL TEST — RAPID DIAGNOSTICS INCAreta 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.DrugCheck — Express Diagnostic Int'l, Inc.DrugSmart Cup — Twin Spirit Inc.DrugCheck — Express Diagnostic Int'l, Inc.DrugCheck — Express Diagnostic Int'l, Inc.Easy@Home Multi-Drug Test Cup (5 tests kit) — EASY HEALTHCARE CORPORATIONUCP Home Drug Screening Test Cups — MEDICAL DISTRIBUTION GROUP INCProScreen — Instant Technologies, Inc.NA — Alere San Diego, Inc.DrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.QuickProfile™ Drugs of Abuse Panel 5 Test — LUMIQUICK DIAGNOSTICS, INC.DrugCheck — Express Diagnostic Int'l, Inc.DrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.iCup® — Instant Technologies, Inc.

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 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
2020-08-18Ameditech 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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.