Enzyme Immunoassay, Cocaine And Cocaine Metabolites
FDA product code DIO · 141 cleared devices
Class 2
Clinical Toxicology
- Regulation
- 21 CFR 862.3250
- Review panel
- TX
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1984-03-19 – 2022-01-27
DIO
2022-01-27
DIO
2021-09-24
DRI Cocaine Metabolite Assay
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DIO
2020-03-12
Pointe Scientific Cocaine Metabolite Enzyme Immunoassay
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DIO
2018-07-06
DRI Cocaine Metabolite Assay
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DIO
2017-10-25
Emit II Plus Cocaine Metabolite Assay
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DIO
2017-08-15
Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
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DIO
2017-06-02
MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
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DIO
2016-11-18
Quest Diagnostics HairCheck-DT (Cocaine)
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DIO
2016-06-27
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard)
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DIO
2016-03-18
SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana
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DIO
2013-11-13
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
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DIO
2013-07-31
WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
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DIO
2012-05-08
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
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DIO
2012-05-08
RANDOX COCAINE METABOLITE
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DIO
2012-04-11
ORATECT ORAL FLUID DRUG SCREEN DEVICES
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DIO
2012-02-01
QUICKSCREEN COCAINE 150 SCREENING TEST
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DIO
2012-01-23
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
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DIO
2011-12-05
AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
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DIO
2011-11-22
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
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DIO
2011-09-23
WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
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DIO
2011-04-08
THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
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DIO
2011-02-11
ROCHE ORAL FLUID COCAINE
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DIO
2009-02-11
RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
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DIO
2006-12-18
QUEST DIAGNOSTICS URINE COCAINE METABOLITE EIA
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DIO
2006-11-16
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV
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DIO
2006-06-15
RAPIDONE-COCAINE-150 TEST
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DIO
2006-05-05
ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000
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DIO
2006-03-29
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS
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DIO
2005-11-18
IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS
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DIO
2005-08-04
IMMUNALYSIS COCAINE ELISA FOR HAIR
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DIO
2005-04-18
ONTRAK TESTCARD 9
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DIO
2004-04-07
CAMP MULTIPLE ANALYTE ENZYME IMMUNOASSAY, CAT.# 0510, 0511 (500 & 5000 TEST KITS)
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DIO
2004-03-05
LABONE COCAINE METABOLITE MICRO-PLATE EIA
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DIO
2004-02-17
ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
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DIO
2004-02-09
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
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DIO
2003-12-23
RANDOX EVIDENCE
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DIO
2003-09-29
AML HAIRCHECK-DT (COCAINE)
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DIO
2003-08-21
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
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DIO
2003-07-23
EMIT II PLUS COCAINE METABOLITE ASSAY
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DIO
2003-04-28
COZART EIA COCAINE ORAL FLIUD KIT
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DIO
2002-12-16
QUICKTOX MULTIPLE DRUG DIPCARD
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DIO
2002-12-06
ONLINE DAT II COCAINE II
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DIO
2002-11-25
COBAS INTEGRA ONLINE DAT II COCAINE II
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DIO
2002-11-06
AMEDICA DRUG SCREEN COCAINE TEST
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DIO
2002-07-30
QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
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DIO
2002-06-10
LIFESIGN COC, STATUS STIK COC, ACCUSIGN STIK COC, ACCUSTIK COC
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DIO
2002-06-10
LIFESIGN COCAINE, MARIJUANA (THC), LIFESIGN DOA2 (THC/COC), STATUS STIK THC/COC, ACCUSIGN STIK THC/COC, ACCUSTIK THC/COC
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DIO
2002-05-15
ACON ONE STEP DRUG SCREEN TEST CARD
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DIO
2002-05-10
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)
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DIO
2002-03-28
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
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DIO
2002-03-13
COCAINE
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DIO
2001-10-22
AMEDITECH IMMUTEST DRUG SCREEN COC
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DIO
2001-08-09
ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
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DIO
2001-07-30
RADS
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DIO
2001-07-09
ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
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DIO
2001-06-25
COCAINE DIPSTICK TEST, MODEL D747-A
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DIO
2001-05-02
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
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DIO
2001-04-17
LIVESURE COCAINE SCREEN TEST
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DIO
2001-04-11
AT WORK DRUG TEST, MODEL 9177T AWT
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DIO
2001-03-30
AT HOME DRUG TEST, MODEL 9073 T
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DIO
2001-01-22
ADVANTAGE THC/COCAINE TEST
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DIO
2000-11-27
BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST
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DIO
2000-08-14
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE DIP STRIP TEST
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DIO
2000-07-27
INSTANT-VIEW COCAINE (BENZYLECGONINE) URINE CASSETTE TEST
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DIO
2000-05-11
COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
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DIO
2000-04-14
URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
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DIO
2000-04-11
SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST
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DIO
2000-04-07
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
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DIO
2000-01-27
SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL
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DIO
1999-12-30
AT HOME DRUG TEST, MODEL 9073
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DIO
1999-12-27
VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE
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DIO
1999-09-20
QUICKPAC II ONE STEP COCAINE TEST
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DIO
1999-09-02
DRUGCHECK X MULTIDRUG SCREENING DEVICE
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DIO
1999-07-26
REDI-TEST COCAINE
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DIO
1999-07-22
QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
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DIO
1999-07-15
RAPIDONE - COCAINE TEST
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DIO
1998-12-11
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
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DIO
1998-11-20
AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
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DIO
1998-11-18
ONTRAK TESTCUP-ER
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DIO
1998-11-18
DBEST COCAINE TEST KIT
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DIO
1998-08-25
STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
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DIO
1998-05-29
MICRO-STRIP FOR COCAINE METABOLITES
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DIO
1998-04-24
MECTEST
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DIO
1998-03-27
DRUG CHECK
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DIO
1998-03-20
RAPID DRUG SCREEN' 8 PANEL
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DIO
1998-01-02
STC COCAINE METABOLITE MICRO-PLATE EIA
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DIO
1997-08-28
QUIKPAC II ONE STEP COCAINE TEST
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DIO
1997-08-06
AQ ONE STEP COCAINE TEST
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DIO
1997-07-14
QUIKSTRIP ONE STEP COCAINE TEST
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DIO
1997-04-14
RAPID DRUG SCREEN
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DIO
1997-04-08
IMMULITE COCAINE METABOLITE
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DIO
1996-08-19
ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)
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DIO
1996-04-02
COCAINE METABOLITE EIA TEST
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DIO
1996-03-06
FRONTLINE COCAINE
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DIO
1995-11-03
ABUSIGN DOA 3, DOA, COC/THC/OPI, ACCUSIGN DOA 3, BIOSIGN DOA 3, COC/THC/OOPI
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DIO
1995-10-26
ABUSIGN DOA 2, DOA, COC/THC, DOA2, BIOSIGN DOA2, COC/THC
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DIO
1995-10-26
ABUSIGN(TM) DOA 4, DOA, THC/OPI/COC/AMP OR MET, BIOSIGN(TM) DOA 4, THC/OPI/COC/AMP OR MET
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DIO
1995-09-25
MECTEST
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DIO
1995-08-17
ONE STEP URINE DRUG OF ABUSE COCAINE TEST
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DIO
1995-08-02
AXSYM COCAINE METABOLITE
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