DJG · Class II · 21 CFR 862.3650

FDA Product Code DJG: Enzyme Immunoassay, Opiates

Accurate detection of opioid use is essential in clinical toxicology, emergency medicine, and workplace drug testing. FDA product code DJG covers enzyme immunoassay systems for the detection of opiates in biological specimens.

These tests use antibody-based technology to identify the presence of opioids — including morphine, codeine, and related compounds — in urine or other samples. They are widely used as initial screening tools before confirmatory testing.

DJG devices are Class II medical devices, regulated under 21 CFR 862.3650 and reviewed by the FDA Toxicology panel.

Leading manufacturers include Lin-Zhi International, Inc., Immunalysis Corporation and Guangzhou Wondfo Biotech Co., Ltd..

215
Total
215
Cleared
132d
Avg days
1984
Since
215 devices
121–144 of 215
Cleared Nov 05, 2002
COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
K020920
Cozart Bioscience , Ltd.
Toxicology · 229d
Cleared Jun 04, 2002
OPIATE ENZYME IMMUNOASSAY, CATALOG # 0020 (500 TESTS KIT)
K020368
Lin-Zhi International, Inc.
Toxicology · 120d
Cleared May 06, 2002
RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
K020716
Rapid Diagnostics, Inc.
Toxicology · 62d
Cleared Apr 03, 2002
UPLINK TEST SYSTEM
K020371
OraSure Technologies, Inc.
Toxicology · 58d
Cleared Mar 20, 2002
RAPIDONE-OXY TEST
K014101
American Bio Medica Corp.
Toxicology · 97d
Cleared Mar 13, 2002
OPIATES
K013314
Abbott Laboratories
Toxicology · 160d
Cleared Dec 21, 2001
ABUSCREEN ONLINE OPIATES 300 / 2000
K013482
Roche Diagnostics Corp.
Toxicology · 63d
Cleared Dec 18, 2001
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
K013380
ACON Laboratories, Inc.
Toxicology · 67d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9084
K013407
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9079
K013408
Phamatech, Inc.
Toxicology · 52d
Cleared Nov 30, 2001
AMEDITECH IMMUTEST DRUG SCREEN OPIATES
K012483
Ameditech, Inc.
Toxicology · 120d
Cleared Jul 30, 2001
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
K011353
ACON Laboratories, Inc.
Toxicology · 88d
Cleared Jun 20, 2001
DRIDAU OPIATE ASSAY
K011150
Microgenics Corp.
Toxicology · 65d
Cleared May 15, 2001
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
K011289
Syva Co., Dade Behring, Inc.
Toxicology · 18d
Cleared Dec 11, 2000
PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR
K000851
Psychemedics Corp.
Toxicology · 271d
Cleared Dec 05, 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
K003209
Dade Behring, Inc.
Toxicology · 53d
Cleared Nov 27, 2000
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST
K002268
Branan Medical Corporation
Toxicology · 125d
Cleared Jun 09, 2000
CEDIA DAU 6-ACETYLMORPHINE ASSAY
K001178
Microgenics Corp.
Toxicology · 59d
Cleared Apr 14, 2000
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
K000464
Dade Behring, Inc.
Toxicology · 63d
Cleared Apr 07, 2000
SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST
K000273
Drug Detection Devices, Ltd.
Toxicology · 70d
Cleared Jan 10, 2000
RADID DRUG SCREEN 5-PANEL TEST
K993151
American Bio Medica Corp.
Toxicology · 111d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9083
K994234
Phamatech
Toxicology · 14d
Cleared Dec 16, 1999
VERDICT -II OPIATES 2000
K992111
Medtox Diagnostics, Inc.
Toxicology · 177d
Cleared Nov 23, 1999
ROCHE COBAS INTEGRA OPIATES 300/2000
K992890
Roche Diagnostics Corp.
Toxicology · 88d