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 02, 1988
EMIT HVA OPIATE ASSAY
Syva Co.
Toxicology
85d
Cleared
Feb 18, 1988
COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5
Diagnostic Products Corp.
Toxicology
87d
Cleared
Feb 11, 1988
REVISED LABELING FOR ADX OPIATES
Abbott Laboratories
Toxicology
38d
Cleared
Nov 23, 1987
REVISED LABELING FOR OPIATES
Abbott Laboratories
Toxicology
24d
Cleared
Nov 13, 1987
REVISED LABELING FOR MORPHINE TEST KIT
Roche Diagnostic Systems, Inc.
Toxicology
24d
Cleared
Oct 29, 1987
REVISED LABELING FOR SYVA OPIATE ASSAYS
Syva Co.
Toxicology
35d
Cleared
Oct 15, 1987
LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE
Diagnostic Products Corp.
Toxicology
41d
Cleared
Oct 15, 1987
LABELING CHANGE COAT-A-COUNT SERUM MORPHINE
Diagnostic Products Corp.
Toxicology
41d
Cleared
Aug 10, 1987
ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD
E.I. Dupont DE Nemours & Co., Inc.
Chemistry
52d
Cleared
Nov 25, 1985
TDX R OPIATES
Abbott Laboratories
Chemistry
21d
Cleared
Sep 26, 1984
EMIT D.A.U. OPIATE ASSAY
Syva Co.
Toxicology
78d
Cleared
Sep 14, 1984
EMIT 700 OPIATE ASSAY
Syva Co.
Toxicology
35d
Cleared
Jan 26, 1984
MODIF. OF EMIT URINE OPIATE ASSAY
Syva Co.
Toxicology
106d