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Enzyme Immunoassay, Amphetamine

FDA product code DKZ · Class 2 · Clinical Toxicology

3,967
Registered devices
62
Adverse events
24
Recalls
225
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.RTCII 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.DrugCheck — Express Diagnostic Int'l, Inc.DrugSmart Cup — Twin Spirit Inc.CAROLINA LIQUID CHEMISTRIES CORP.® AMPH RGT. KIT MR412 — CAROLINA LIQUID CHEMISTRIES CORPORATIONEasy@Home Multi-Drug Test Cup (5 tests kit) — EASY HEALTHCARE CORPORATIONUCP — UCP BIOSCIENCES, INC.UCP Home Drug Screening Test Cups — MEDICAL DISTRIBUTION GROUP INCProScreen — Instant Technologies, Inc.DrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.QuickProfile™ Drugs of Abuse Panel 5 Test — LUMIQUICK DIAGNOSTICS, INC.DrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.Amphetamines II — Roche Diagnostics GmbH

Recent recalls

DateFirmReason
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot
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
2017-11-14Alere San Diego, Inc.The recalled lots have demonstrated unexpected false positive THC results.
2014-09-23Ameditech IncAmeditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on
2014-09-23Ameditech IncAmeditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on
2014-09-23Ameditech IncAmeditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on
2013-07-29Sarken, Inc.These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of
2013-07-29Sarken, Inc.These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of

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