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
Cleared
Aug 12, 2021
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
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
Psychemedics Corporation
Toxicology
434d
Cleared
Sep 17, 2020
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Advin Biotech, Inc.
Toxicology
104d
Cleared
Sep 17, 2020
LZI Oxycodone III Enzyme Immunoassay
Lin-Zhi International, Inc.
Toxicology
58d
Cleared
Aug 07, 2020
LZI Fentanyl II Enzyme Immunoassay
Lin-Zhi International, Inc.
Chemistry
25d
Cleared
Jun 04, 2020
LZI Tramadol Enzyme Immunoassay
Lin-Zhi International, Inc.
Toxicology
29d
Cleared
Feb 26, 2020
ARK Fentanyl II Assay
ARK Diagnostics, Inc.
Toxicology
30d
Cleared
Dec 16, 2019
CEDIA Heroin Metabolite (6-AM) assay
Microgenics Corporation
Toxicology
59d
Cleared
Apr 18, 2019
Psychemedics Microplate EIA for Fentanyl in Hair
Psychemedics Corporation
Toxicology
258d
Cleared
Mar 29, 2019
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Advin Biotech, Inc.
Toxicology
235d
Cleared
Dec 10, 2018
ARK Tramadol Assay
ARK Diagnostics, Inc.
Toxicology
110d
Cleared
Dec 03, 2018
LZI Fentanyl Enzyme Immunoassay
Lin-Zhi International, Inc.
Toxicology
216d
Cleared
Jun 06, 2018
ARK Fentanyl Assay
ARK Diagnostics, Inc.
Toxicology
110d
Cleared
Apr 19, 2018
Synermed Opiate Enzyme Immunoassay
Infrared Laboratory Systems, LLC (Dba Synermed)
Toxicology
252d
Cleared
Feb 13, 2018
DRI Hydrocodone Assay
Microgenics Corporation
Toxicology
134d
Cleared
Nov 22, 2017
CEDIA Heroin Metabolite (6-AM) Assay
Microgenics Corporation
Toxicology
51d
Cleared
Oct 18, 2017
Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics, Inc.
Toxicology
23d
Cleared
Jun 14, 2017
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
Immunalysis Corporation
Toxicology
411d
Cleared
Apr 06, 2017
CEDIA Buprenorphine II Assay
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
Siemens Healthcare Diagnostics, Inc.
Toxicology
227d
Cleared
Jul 01, 2015
Wondfo CR3 Keyless Split Sample Cup
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
Immunalysis Corporation
Toxicology
161d
Cleared
Mar 09, 2015
Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls
Immunalysis Corporation
Toxicology
33d
Cleared
Feb 25, 2015
CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology
29d