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
49–72 of 215
Cleared Feb 13, 2015
LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
K141205
Lin-Zhi International, Inc.
Toxicology · 280d
Cleared Feb 12, 2015
IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY
K141803
Immunalysis Corporation
Toxicology · 224d
Cleared Jul 01, 2014
IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
K141406
Immunalysis Corporation
Toxicology · 34d
Cleared Jun 13, 2014
LZI HYDROCODONE
K141055
Lin-Zhi International, Inc.
Toxicology · 50d
Cleared Apr 08, 2014
CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
K140089
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 84d
Cleared Feb 26, 2014
STATUS DS OXY
K130650
Princeton BioMeditech Corp.
Toxicology · 352d
Cleared Jan 17, 2014
IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
K131168
Immunalysis Corporation
Toxicology · 268d
Cleared Apr 09, 2013
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
K130665
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 28d
Cleared Feb 14, 2013
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
K130055
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 36d
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 Mar 12, 2012
WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
K113624
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 95d
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 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 Jul 30, 2009
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
K090844
Lin-Zhi International, Inc.
Toxicology · 125d
Cleared Dec 22, 2008
BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
K081008
Lin-Zhi International, Inc.
Toxicology · 256d
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 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