LDJ · Class II · 21 CFR 862.3870

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
25–48 of 150
Cleared Apr 06, 2000
URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A
K000461
Dade Behring, Inc.
Toxicology · 55d
Cleared Feb 04, 2000
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
K000131
Phamatech
Toxicology · 17d
Cleared Jan 18, 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984
Syva Co.
Toxicology · 55d
Cleared Dec 30, 1999
AT HOME DRUG TEST, MODEL 9078
K994220
Phamatech
Toxicology · 15d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
K983701
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
K981584
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
K981585
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared Sep 25, 1997
QUICKSCREEN ONE STEP THC SCREENING TEST
K973122
Phamatech
Toxicology · 36d
Cleared Jul 03, 1997
ONE STEP MARIJUANA CARD TEST
K970548
Teco Diagnostics
Toxicology · 141d
Cleared Apr 28, 1997
IMMULITE CANNABINOIDS
K963916
Diagnostic Products Corp.
Toxicology · 210d
Cleared Apr 03, 1996
SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
K955677
Beckman Instruments, Inc.
Toxicology · 110d
Cleared Mar 06, 1996
FRONTLINE CANNABIS
K954497
Boehringer Mannheim Corp.
Toxicology · 161d
Cleared Apr 05, 1995
URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE
K950181
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 78d
Cleared Feb 22, 1995
EMIT IIC CANNABINOID ASSAY
K940158
Syva Co.
Toxicology · 406d
Cleared Feb 22, 1995
ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC
K945550
Princeton BioMeditech Corp.
Toxicology · 100d
Cleared Dec 29, 1994
CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS
K944086
Beckman Instruments, Inc.
Toxicology · 177d
Cleared Nov 21, 1994
CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS
K944088
Beckman Instruments, Inc.
Toxicology · 139d
Cleared Nov 04, 1994
CANNABINOID EIA ASSAY
K943998
Diagnostic Reagents, Inc.
Toxicology · 136d
Cleared Nov 02, 1994
MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION
K944562
Microgenics Corp.
Chemistry · 64d
Cleared Aug 01, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K942337
Microgenics Corp.
Toxicology · 77d
Cleared May 17, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT
K940649
Microgenics Corp.
Toxicology · 91d
Cleared Jan 13, 1994
CEDIA DAU MULTI-LEVEL THC ASSAY
K935591
Microgenics Corp.
Toxicology · 55d
Cleared Oct 01, 1993
EMIT(R) THC 50/100 NG ASSAY
K932716
Syva Co.
Toxicology · 119d
Cleared May 12, 1993
BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)
K931598
Biosite Incorporated
Toxicology · 41d