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
Apr 06, 2000
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
Dade Behring, Inc.
Toxicology
55d
Cleared
Feb 04, 2000
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
Phamatech
Toxicology
17d
Cleared
Jan 18, 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
Syva Co.
Toxicology
55d
Cleared
Dec 30, 1999
AT HOME DRUG TEST, MODEL 9078
Phamatech
Toxicology
15d
Cleared
Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
Roche Diagnostic Systems, Inc.
Toxicology
51d
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
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
Apr 28, 1997
IMMULITE CANNABINOIDS
Diagnostic Products Corp.
Toxicology
210d
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
Apr 05, 1995
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
78d
Cleared
Feb 22, 1995
EMIT IIC CANNABINOID ASSAY
Syva Co.
Toxicology
406d
Cleared
Feb 22, 1995
ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC
Princeton BioMeditech Corp.
Toxicology
100d
Cleared
Dec 29, 1994
CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS
Beckman Instruments, Inc.
Toxicology
177d
Cleared
Nov 21, 1994
CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS
Beckman Instruments, Inc.
Toxicology
139d
Cleared
Nov 04, 1994
CANNABINOID EIA ASSAY
Diagnostic Reagents, Inc.
Toxicology
136d
Cleared
Nov 02, 1994
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION
Microgenics Corp.
Chemistry
64d
Cleared
Aug 01, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
Microgenics Corp.
Toxicology
77d
Cleared
May 17, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT
Microgenics Corp.
Toxicology
91d
Cleared
Jan 13, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
Microgenics Corp.
Toxicology
55d
Cleared
Oct 01, 1993
EMIT(R) THC 50/100 NG ASSAY
Syva Co.
Toxicology
119d
Cleared
May 12, 1993
BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)
Biosite Incorporated
Toxicology
41d