Enzyme Immunoassay, Cannabinoids

FDA product code LDJ · 145 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3870
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1981-08-20 – 2024-01-17

LDJ 2024-01-17

Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50

Applicant Co-Innovation Biotech Co., Ltd.

K number K232732

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LDJ 2024-01-10

LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)

Applicant Hangzhou Laihe Biotech Co., Ltd.

K number K232604

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LDJ 2023-03-17

Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT

Applicant Healgen Scientific,, LLC

K number K223162

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LDJ 2019-10-11

BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20

Applicant Shenzhen Bioeasy Biotechnology Co., Ltd.

K number K192515

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LDJ 2016-03-18

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test

Applicant Hangzhou Clongene Biotech Co., Ltd.

K number K153741

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LDJ 2013-10-18

RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR

Applicant Biophor Diagnostics, Inc.

K number K132096

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LDJ 2013-10-18

QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE

Applicant Lumiquick Diagnostics, Inc.

K number K130213

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LDJ 2013-02-07

TOXCUP DRUG SCREEN CUP

Applicant Branan Medical Corp.

K number K122633

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LDJ 2012-12-05

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)

Applicant Omega Laboratories, Inc.

K number K122759

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LDJ 2012-07-25

WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K number K121557

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LDJ 2012-05-01

PSYCHEMEDICS CANNABINOIDS EIA

Applicant Psychemedics Corp.

K number K111929

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LDJ 2012-04-18

WUNDER TEST

Applicant Hien Helen Nguyen

K number K102428

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LDJ 2011-06-23

LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL

Applicant Lin-Zhi International, Inc.

K number K110239

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LDJ 2011-05-20

CANNABINOIDS URINE TEST

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K number K110182

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LDJ 2011-04-08

THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY

Applicant Microgenics Corp.

K number K101744

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LDJ 2011-04-08

CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET

Applicant Randox Laboratories, Ltd.

K number K092269

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LDJ 2009-08-20

BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP

Applicant Mk Bio, Inc.

K number K082977

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LDJ 2008-11-25

BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,

Applicant Applied Dna Technologies, Inc.

K number K080467

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LDJ 2008-08-19

AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ

Applicant Amedica Biotech, Inc.

K number K080872

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LDJ 2006-12-28

VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV

Applicant Ortho-Clinical Diagnostics, Inc.

K number K063164

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LDJ 2006-07-21

AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020

Applicant Amedica Biotech, Inc.

K number K061556

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LDJ 2006-06-06

ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000

Applicant Acro Biotech, LLC

K number K053034

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LDJ 2005-06-24

ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE

Applicant ACON Laboratories, Inc.

K number K050936

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LDJ 2005-06-08

ON CALL MULTI-DRUG HOME TEST CUP

Applicant ACON Laboratories, Inc.

K number K050878

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LDJ 2005-05-15

NANO-CHECK DAT 5 MULTI DRUG SCREENING TEST FOR CANNABINOIDS, OPIATES, COCAINE, METHAMPHETAMINE & PHENCYCLIDINE

Applicant Nano-Ditech Co.

K number K050594

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LDJ 2005-03-11

ON CALL MULTI-DRUG HOME TEST

Applicant ACON Laboratories, Inc.

K number K050050

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LDJ 2004-11-23

RANDOX CANNABINOIDS ASSSAY

Applicant Randox Laboratories, Ltd.

K number K041142

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LDJ 2004-07-13

ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY

Applicant Accu-Stat Diagnostics, Inc.

K number K041221

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LDJ 2004-06-14

QUEST DIAGNOSTICS HAIRCHECK-DT (THC)

Applicant Quest Diagnostics, Inc.

K number K040257

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LDJ 2004-05-17

AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST

Applicant Amedica Biotech, Inc.

K number K040464

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LDJ 2004-05-05

ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE

Applicant Accu-Stat Diagnostics, Inc.

K number K040629

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LDJ 2003-05-06

VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI

Applicant Sun Biomedical Laboratories, Inc.

K number K023648

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LDJ 2003-04-11

ONLINE DAT II CANNABINOIDS II

Applicant Roche Diagnostics Corp.

K number K030213

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LDJ 2002-11-06

AMEDICA DRUG SCREEN THC TEST

Applicant Amedica Biotech, Inc.

K number K022955

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LDJ 2002-08-15

CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071

Applicant Lin-Zhi International, Inc.

K number K021887

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LDJ 2002-06-10

LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC

Applicant Princeton BioMeditech Corp.

K number K014066

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LDJ 2002-05-23

LIFESIGN DOA 4 (THC/OPI/COC/MET)

Applicant Princeton BioMeditech Corp.

K number K014193

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LDJ 2002-03-13

CANNABINOIDS

Applicant Abbott Laboratories

K number K013247

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LDJ 2001-12-18

NO STEP ON SITE DEUG TEST CUP

Applicant Drug Free Enterprises

K number K012390

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LDJ 2001-10-22

AMEDITECH IMMUTEST DRUG SCREEN THC

Applicant Ameditech, Inc.

K number K011813

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LDJ 2001-09-04

MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET

Applicant Branan Medical Corp.

K number K012541

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LDJ 2001-06-25

ADVANTAGE MARIJUANA (THC) HOME DRUG TEST

Applicant Advantage Diagnostics Corp.

K number K010921

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LDJ 2001-05-17

EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229

Applicant Syva Co., Dade Behring, Inc.

K number K011300

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LDJ 2001-03-15

ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE)

Applicant ACON Laboratories, Inc.

K number K003557

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LDJ 2001-02-14

PROFILE II ER

Applicant Medtox Diagnostics, Inc.

K number K010138

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LDJ 2001-02-05

LIVESURE THC SCREEN TEST

Applicant Pan Probe Biotech, Inc.

K number K010001

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LDJ 2001-01-26

STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I

Applicant OraSure Technologies, Inc.

K number K002375

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LDJ 2000-11-27

BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST

Applicant Branan Medical Corp.

K number K002263

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LDJ 2000-08-07

PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST

Applicant Alatex Scientific, Inc.

K number K001126

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LDJ 2000-06-23

FIRST CHECK HOME DRUG TEST PANEL 2

Applicant Worldwide Medical Corp.

K number K994139

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LDJ 2000-06-23

FIRST CHECK HOME DRUG TEST PANEL 3

Applicant Worldwide Medical Corp.

K number K994138

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LDJ 2000-06-23

FIRST CHECK HOME DRUG TEST (THC)

Applicant Worldwide Medical Corp.

K number K993663

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LDJ 2000-06-21

INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST

Applicant Alfa Scientific Designs, Inc.

K number K994410

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LDJ 2000-06-19

ADVANTAGE THC TEST

Applicant Advantage Diagnostics Corp.

K number K001567

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LDJ 2000-04-13

ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579

Applicant Roche Diagnostics Corp.

K number K994164

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LDJ 2000-04-06

URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A

Applicant Dade Behring, Inc.

K number K000461

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LDJ 2000-02-04

QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04

Applicant Phamatech

K number K000131

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LDJ 2000-01-24

RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)

Applicant American Bio Medica Corp.

K number K993961

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LDJ 2000-01-18

SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL

Applicant Syva Co.

K number K993984

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LDJ 1999-12-30

AT HOME DRUG TEST, MODEL 9078

Applicant Phamatech

K number K994220

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LDJ 1999-12-27

SCREENERS MARIJUANA TEST, DRUGSCREEN DIP MARIJUANA TEST

Applicant Drug Detection Devices, Ltd.

K number K992949

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LDJ 1999-12-21

RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE

Applicant American Bio Medica Corp.

K number K993796

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LDJ 1999-08-05

MICRO-STRIP FOR MARIJUANA METABOLITES

Applicant Microdiagnostics, Inc.

K number K991516

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LDJ 1999-07-07

RAPIDONE - MARIJUANA TEST

Applicant American Bio Medica Corp.

K number K990818

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LDJ 1999-04-27

REDI-TEST THC

Applicant Redwood Biotech, Inc.

K number K990870

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LDJ 1998-12-11

MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS

Applicant Roche Diagnostic Systems, Inc.

K number K983701

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LDJ 1998-11-18

DBEST TETRAHYDROCANNABINOL TEST KIT

Applicant Ameritek, Inc.

K number K983188

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LDJ 1998-07-22

UBI MAGIWEL MARIJUANA METABOLITES

Applicant United Biotech, Inc.

K number K973154

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LDJ 1998-06-29

GENIE CUP INTEGRATED SCREENING DEVICE

Applicant Applied Technology Ventures, LLC

K number K980836

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LDJ 1998-05-28

ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)

Applicant Roche Diagnostic Systems, Inc.

K number K981585

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LDJ 1998-05-28

ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)

Applicant Roche Diagnostic Systems, Inc.

K number K981584

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LDJ 1998-02-13

STC CANNABINOIDS MICRO-PLATE EIA

Applicant OraSure Technologies, Inc.

K number K973750

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LDJ 1997-09-25

QUICKSCREEN ONE STEP THC SCREENING TEST

Applicant Phamatech

K number K973122

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LDJ 1997-07-03

ONE STEP MARIJUANA CARD TEST

Applicant Teco Diagnostics

K number K970548

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LDJ 1997-06-25

BIONIKE AQ ONE STEP CANNABINOIDS (THC) TEST

Applicant Bionike Laboratories, Inc.

K number K971841

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LDJ 1997-04-28

IMMULITE CANNABINOIDS

Applicant Diagnostic Products Corp.

K number K963916

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LDJ 1997-02-28

QUIKSTRIP ONESTEP MARIJUANA (THC) TEST

Applicant Syntron Bioresearch, Inc.

K number K963654

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LDJ 1997-02-20

QUICKPAC II ONE STEP MARIJUANA (THC) TEST

Applicant Drial Consultants, Inc.

K number K963207

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LDJ 1996-10-30

VISUALINE COMBO V (COCAINE/THC) TEST

Applicant Sun Biomedical Laboratories, Inc.

K number K963606

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LDJ 1996-10-30

VERDICT THC

Applicant Editek, Inc.

K number K963516

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LDJ 1996-08-20

ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)

Applicant Tcpi, Inc.

K number K951853

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LDJ 1996-04-03

SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT

Applicant Beckman Instruments, Inc.

K number K955677

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LDJ 1996-03-06

FRONTLINE CANNABIS

Applicant Boehringer Mannheim Corp.

K number K954497

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LDJ 1995-05-02

VISUALINE II CANNABINOIDS (THC)

Applicant Sun Biomedical Laboratories, Inc.

K number K950445

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LDJ 1995-04-05

URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K950181

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LDJ 1995-02-22

ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC

Applicant Princeton BioMeditech Corp.

K number K945550

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LDJ 1995-02-22

EMIT IIC CANNABINOID ASSAY

Applicant Syva Co.

K number K940158

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LDJ 1994-12-29

CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS

Applicant Beckman Instruments, Inc.

K number K944086

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LDJ 1994-11-21

CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS

Applicant Beckman Instruments, Inc.

K number K944088

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LDJ 1994-11-04

CANNABINOID EIA ASSAY

Applicant Diagnostic Reagents, Inc.

K number K943998

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LDJ 1994-11-02

MULTI LEVEL THC ASSAY, SYNCHRON CX REAGENT APPLICATION

Applicant Microgenics Corp.

K number K944562

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LDJ 1994-08-01

CEDIA DAU MULTI-LEVEL THC ASSAY

Applicant Microgenics Corp.

K number K942337

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LDJ 1994-06-02

USDT CANNABINOID (THC) ASSAY COLUMN CATALOG NO. 9000-500

Applicant U.S. Drug Testing, Inc.

K number K940912

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LDJ 1994-05-17

CEDIA DAU MULTI-LEVEL THC ASSAY, HITACHI 911 REAGENT/ AND THE HITACHI 747 REAGENT

Applicant Microgenics Corp.

K number K940649

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LDJ 1994-01-13

CEDIA DAU MULTI-LEVEL THC ASSAY

Applicant Microgenics Corp.

K number K935591

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LDJ 1993-10-01

EMIT(R) THC 50/100 NG ASSAY

Applicant Syva Co.

K number K932716

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LDJ 1993-05-12

BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML)

Applicant Biosite Incorporated

K number K931598

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LDJ 1993-05-06

STC DIAGNOSTICS AUTO-LYTE CANNABINOIDS EIA

Applicant Solarcare Technologies Corp,Inc.

K number K930654

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LDJ 1993-01-26

MICROPLATE CANNABINOIDS ASSAY

Applicant Solarcare Technologies Corp,Inc.

K number K924815

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LDJ 1992-02-27

IL TEST CANNABINOID, 35282

Applicant Instrumentation Laboratory CO

K number K920418

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