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 Syva Co., Lin-Zhi International, Inc. and Diagnostic Products Corp..

215
Total
215
Cleared
132d
Avg days
1984
Since
215 devices
25–48 of 215
Cleared Aug 12, 2021
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
K201630
Assure Tech. (Hangzhou) Co, Ltd.
Toxicology · 422d
Cleared Jul 27, 2021
Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
K201326
Psychemedics Corporation
Toxicology · 434d
Cleared Sep 17, 2020
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
K201494
Advin Biotech, Inc.
Toxicology · 104d
Cleared Sep 17, 2020
LZI Oxycodone III Enzyme Immunoassay
K202007
Lin-Zhi International, Inc.
Toxicology · 58d
Cleared Aug 07, 2020
LZI Fentanyl II Enzyme Immunoassay
K201938
Lin-Zhi International, Inc.
Chemistry · 25d
Cleared Jun 04, 2020
LZI Tramadol Enzyme Immunoassay
K201223
Lin-Zhi International, Inc.
Toxicology · 29d
Cleared Feb 26, 2020
ARK Fentanyl II Assay
K200197
ARK Diagnostics, Inc.
Toxicology · 30d
Cleared Dec 16, 2019
CEDIA Heroin Metabolite (6-AM) assay
K192943
Microgenics Corporation
Toxicology · 59d
Cleared Apr 18, 2019
Psychemedics Microplate EIA for Fentanyl in Hair
K182103
Psychemedics Corporation
Toxicology · 258d
Cleared Mar 29, 2019
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
K182123
Advin Biotech, Inc.
Toxicology · 235d
Cleared Dec 10, 2018
ARK Tramadol Assay
K182280
ARK Diagnostics, Inc.
Toxicology · 110d
Cleared Dec 03, 2018
LZI Fentanyl Enzyme Immunoassay
K181159
Lin-Zhi International, Inc.
Toxicology · 216d
Cleared Jun 06, 2018
ARK Fentanyl Assay
K180427
ARK Diagnostics, Inc.
Toxicology · 110d
Cleared Apr 19, 2018
Synermed Opiate Enzyme Immunoassay
K172416
Infrared Laboratory Systems, LLC (Dba Synermed)
Toxicology · 252d
Cleared Feb 13, 2018
DRI Hydrocodone Assay
K173195
Microgenics Corporation
Toxicology · 134d
Cleared Nov 22, 2017
CEDIA Heroin Metabolite (6-AM) Assay
K173183
Microgenics Corporation
Toxicology · 51d
Cleared Oct 18, 2017
Emit II Plus Oxycodone Assay
K172910
Siemens Healthcare Diagnostics, Inc.
Toxicology · 23d
Cleared Jun 14, 2017
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
K161216
Immunalysis Corporation
Toxicology · 411d
Cleared Apr 06, 2017
CEDIA Buprenorphine II Assay
K163101
Microgenics Corporation
Toxicology · 150d
Cleared Oct 23, 2015
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
K150606
Siemens Healthcare Diagnostics, Inc.
Toxicology · 227d
Cleared Jul 01, 2015
Wondfo CR3 Keyless Split Sample Cup
K151478
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d
Cleared May 20, 2015
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
K143502
Immunalysis Corporation
Toxicology · 161d
Cleared Mar 09, 2015
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls
K150275
Immunalysis Corporation
Toxicology · 33d
Cleared Feb 25, 2015
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
K150179
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 29d