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
Dec 21, 1999
RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE
American Bio Medica Corp.
Toxicology
42d
Cleared
Aug 05, 1999
MICRO-STRIP FOR MARIJUANA METABOLITES
Microdiagnostics, Inc.
Toxicology
97d
Cleared
Jul 07, 1999
RAPIDONE - MARIJUANA TEST
American Bio Medica Corp.
Toxicology
118d
Cleared
Apr 27, 1999
REDI-TEST THC
Redwood Biotech, Inc.
Toxicology
42d
Cleared
Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
Roche Diagnostic Systems, Inc.
Toxicology
51d
Cleared
Nov 18, 1998
DBEST TETRAHYDROCANNABINOL TEST KIT
Ameritek, Inc.
Toxicology
68d
Cleared
Jul 22, 1998
UBI MAGIWEL MARIJUANA METABOLITES
United Biotech, Inc.
Toxicology
334d
Cleared
Jun 29, 1998
GENIE CUP INTEGRATED SCREENING DEVICE
Applied Technology Ventures, LLC
Toxicology
117d
Cleared
May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
Roche Diagnostic Systems, Inc.
Toxicology
24d
Cleared
May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
Roche Diagnostic Systems, Inc.
Toxicology
24d
Cleared
Feb 13, 1998
STC CANNABINOIDS MICRO-PLATE EIA
OraSure Technologies, Inc.
Toxicology
135d
Cleared
Sep 25, 1997
QUICKSCREEN ONE STEP THC SCREENING TEST
Phamatech
Toxicology
36d
Cleared
Jul 03, 1997
ONE STEP MARIJUANA CARD TEST
Teco Diagnostics
Toxicology
141d
Cleared
Jun 25, 1997
BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST
Bionike Laboratories, Inc.
Toxicology
37d
Cleared
Apr 28, 1997
IMMULITE CANNABINOIDS
Diagnostic Products Corp.
Toxicology
210d
Cleared
Feb 28, 1997
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
Syntron Bioresearch, Inc.
Toxicology
169d
Cleared
Feb 20, 1997
QUICKPAC II ONE STEP MARIJUANA (THC) TEST
Drial Consultants, Inc.
Toxicology
189d
Cleared
Oct 30, 1996
VERDICT THC
Editek, Inc.
Toxicology
57d
Cleared
Oct 30, 1996
VISUALINE COMBO V (COCAINE/THC) TEST
Sun Biomedical Laboratories, Inc.
Chemistry
51d
Cleared
Aug 20, 1996
ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
Tcpi, Inc.
Toxicology
487d
Cleared
Apr 03, 1996
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
Beckman Instruments, Inc.
Toxicology
110d
Cleared
Mar 06, 1996
FRONTLINE CANNABIS
Boehringer Mannheim Corp.
Toxicology
161d
Cleared
May 02, 1995
VISUALINE II CANNABINOIDS (THC)
Sun Biomedical Laboratories, Inc.
Toxicology
95d
Cleared
Apr 05, 1995
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
78d