FDA Product Code LDJ: Enzyme Immunoassay, Cannabinoids
Cannabis use is widespread and its detection is required in workplace and forensic settings. FDA product code LDJ covers enzyme immunoassay systems for cannabinoid detection in biological specimens.
These tests detect THC metabolites — particularly 11-nor-9-carboxy-THC — in urine, enabling screening for cannabis use in workplace drug testing, probation monitoring, and clinical settings. Cannabis metabolites can be detected for days to weeks after use.
LDJ devices are Class II medical devices, regulated under 21 CFR 862.3870 and reviewed by the FDA Toxicology panel.
Leading manufacturers include Syva Co., Roche Diagnostic Systems, Inc. and Abbott Laboratories.
150
Total
150
Cleared
112d
Avg days
1981
Since
150 devices
Cleared
Jun 21, 1991
ABUSCREEN FP FOR CANNABINOIDS (15-50)
Roche Diagnostic Systems, Inc.
Toxicology
129d
Cleared
Apr 03, 1991
ABUSCREEN FP FOR CANNABINOIDS (50-100)
Roche Diagnostic Systems, Inc.
Toxicology
50d
Cleared
Dec 26, 1990
EMIT(R) II CANNABINOID 100 NG ASSAY
Syva Co.
Toxicology
78d
Cleared
Dec 26, 1990
EMIT(R) II CANNABINOID 20 NG ASSAY
Syva Co.
Toxicology
78d
Cleared
Dec 26, 1990
EMIT(R) II CANNABINOID 50 NG ASSAY
Syva Co.
Toxicology
78d
Cleared
Dec 13, 1990
ABUSCREEN ONTRAK FOR THC
Roche Diagnostic Systems, Inc.
Toxicology
45d
Cleared
Nov 20, 1990
LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS
Abbott Laboratories
Toxicology
47d
Cleared
May 17, 1990
MILENIA(TM) CANNABINOIDS
Diagnostic Products Corp.
Toxicology
43d
Cleared
Aug 25, 1989
ADX CANNABINOIDS
Abbott Laboratories
Toxicology
196d
Cleared
Mar 16, 1989
ABUSCREEN FP FOR CANNABINOIDS
Roche Diagnostic Systems, Inc.
Toxicology
23d
Cleared
Oct 11, 1988
TDX CANNABINOIDS-GS
Abbott Laboratories
Toxicology
41d
Cleared
Aug 29, 1988
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS
Syva Co.
Toxicology
87d
Cleared
Aug 08, 1988
EMIT HVA CANNABINOID 100 NG ASSAY
Syva Co.
Toxicology
31d
Cleared
Jul 29, 1988
ABUSCREEN(R) ONTRAK(TM) FOR THC
Roche Diagnostic Systems, Inc.
Toxicology
92d
Cleared
Mar 01, 1988
REVISED LABELING FOR ADX CANNABINOIDS
Abbott Laboratories
Toxicology
57d
Cleared
Feb 03, 1988
ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
43d
Cleared
Dec 18, 1987
TDXR DELTA-9-CANNABINOIDS
Abbott Laboratories
Chemistry
35d
Cleared
Nov 23, 1987
REVISED LABELING FOR TDX CANNABINOIDS
Abbott Laboratories
Toxicology
24d
Cleared
Nov 20, 1987
REVISED LABELING FOR CANNABINOIDS TEST KIT
Roche Diagnostic Systems, Inc.
Toxicology
31d
Cleared
Oct 28, 1987
REVISED LABELING FOR SYVA CANNABINOID ASSAYS
Syva Co.
Toxicology
22d
Cleared
Oct 28, 1987
STICKER LABEL FOR DRUGS OF ABUSE ASSAYS
Syva Co.
Toxicology
15d
Cleared
Oct 15, 1987
LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE
Diagnostic Products Corp.
Toxicology
41d
Cleared
Jun 05, 1987
DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5
Diagnostic Products Corp.
Toxicology
36d
Cleared
Mar 16, 1987
ABUSCREEN (R) EIA CANNABINOIDS
Roche Diagnostic Systems, Inc.
Toxicology
46d