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 Syva Co..

215
Total
215
Cleared
132d
Avg days
1984
Since
215 devices
73–96 of 215
Cleared Jun 01, 2012
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
K120763
Lin-Zhi International, Inc.
Toxicology · 80d
Cleared May 08, 2012
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
K120761
Lin-Zhi International, Inc.
Toxicology · 56d
Cleared May 01, 2012
PSYCHEMEDICS OPIATES EIA
K111926
Psychemedics Corp.
Toxicology · 300d
Cleared Mar 12, 2012
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
K113624
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 95d
Cleared Dec 13, 2011
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES
K103161
Omega Laboratories, Inc.
Toxicology · 412d
Cleared Sep 08, 2011
WONDFO METHADONE URINE TEST,OPIATE TEST
K112310
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared Jul 15, 2011
OPIATE ENZYME IMMUNOASSAY
K110298
Lin-Zhi International, Inc.
Chemistry · 164d
Cleared Apr 08, 2011
THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
K101754
Microgenics Corp.
Toxicology · 290d
Cleared Mar 18, 2011
EMIT II PLUS6-ACETYLMORPHINE ASSAY
K102779
Siemens Healthcare Diagnostics, Inc.
Chemistry · 175d
Cleared Feb 11, 2011
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
K093867
Roche Diagnostics
Chemistry · 402d
Cleared Oct 18, 2010
MEDTOX BUPRENORPHINE TEST
K100951
Medtox Diagnostics, Inc.
Chemistry · 195d
Cleared Aug 25, 2010
WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES
K093175
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 321d
Cleared Jul 06, 2010
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
K100051
Alfa Scientific Designs, Inc.
Toxicology · 179d
Cleared Jul 06, 2010
6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS
K101195
Lin-Zhi International, Inc.
Chemistry · 68d
Cleared Apr 05, 2010
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
K100023
Medtox Diagnostics, Inc.
Toxicology · 90d
Cleared Feb 24, 2010
UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST
K091612
Ucp Biosciences, Inc.
Toxicology · 266d
Cleared Jul 30, 2009
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
K090844
Lin-Zhi International, Inc.
Toxicology · 125d
Cleared Jul 24, 2009
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
K091454
Medtox Diagnostics, Inc.
Toxicology · 67d
Cleared Dec 22, 2008
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
K081008
Lin-Zhi International, Inc.
Toxicology · 256d
Cleared Nov 21, 2008
FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD
K082508
Branan Medical Corporation
Toxicology · 84d
Cleared Jun 01, 2007
IMDX SYSTEMS
K063699
Novx Systems, Inc.
Chemistry · 170d
Cleared May 07, 2007
MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
K063545
Alfa Scientific Designs, Inc.
Toxicology · 164d
Cleared Dec 20, 2006
AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150
K063015
Ameditech, Inc.
Toxicology · 79d
Cleared Dec 15, 2006
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III
K062460
Ortho-Clinical Diagnostics, Inc.
Chemistry · 114d