Enzyme Immunoassay, Opiates
FDA product code DJG · 194 cleared devices
Class 2
Clinical Toxicology
- Regulation
- 21 CFR 862.3650
- Review panel
- TX
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1984-01-26 – 2026-01-29
DJG
2002-06-04
DJG
2002-05-06
RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)
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DJG
2002-04-03
UPLINK TEST SYSTEM
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DJG
2002-03-20
RAPIDONE-OXY TEST
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DJG
2002-03-13
OPIATES
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DJG
2001-12-21
ABUSCREEN ONLINE OPIATES 300 / 2000
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DJG
2001-12-18
ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE
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DJG
2001-12-06
AT HOME DRUG TEST, MODEL 9079
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DJG
2001-12-06
AT HOME DRUG TEST, MODEL 9084
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DJG
2001-11-30
AMEDITECH IMMUTEST DRUG SCREEN OPIATES
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DJG
2001-07-30
ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE
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DJG
2001-06-20
DRIDAU OPIATE ASSAY
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DJG
2001-05-15
EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
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DJG
2000-12-11
PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR
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DJG
2000-12-05
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
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DJG
2000-11-27
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST
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DJG
2000-06-09
CEDIA DAU 6-ACETYLMORPHINE ASSAY
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DJG
2000-04-14
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
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DJG
2000-04-07
SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST
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DJG
2000-01-10
RADID DRUG SCREEN 5-PANEL TEST
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DJG
1999-12-30
AT HOME DRUG TEST, MODEL 9083
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DJG
1999-12-16
VERDICT -II OPIATES 2000
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DJG
1999-11-23
ROCHE COBAS INTEGRA OPIATES 300/2000
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DJG
1999-10-29
QUICKPAC II ONE STEP OPIATES TEST
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DJG
1999-10-29
QUICKSTRIP ONE STEP OPIATES TEST
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DJG
1999-10-20
QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
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DJG
1999-09-15
REDI-TEST OPIATES
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DJG
1999-08-10
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000
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DJG
1999-07-15
RAPIDONE - OPIATES TEST
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DJG
1999-01-29
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
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DJG
1999-01-22
MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
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DJG
1998-11-18
DBEST OPIATES TEST KIT
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DJG
1998-06-12
ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP
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DJG
1998-05-22
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
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DJG
1998-04-24
ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL
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DJG
1997-12-24
MICRO-STRIP FOR OPIATE METABOLITES
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DJG
1997-10-28
UBI MAGIWEL COCAINE METABOLITES
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DJG
1997-10-28
UBI MAGIWEL OPIATE METABOLITES
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DJG
1997-10-28
UBI MAGIWEL AMPHETAMINE METABOLITES
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DJG
1997-08-20
QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)
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DJG
1997-08-20
QUIKSTRIP ONE STEP OPIATES TEST
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DJG
1997-08-08
QUIKPAC II ONE STEP OPIATE TEST
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DJG
1997-06-25
EMIT II OPIATES 300/2000 ASSAY
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DJG
1997-06-06
AQ OPIATES (MORPHINE) TEST
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DJG
1997-03-10
IMMULITE OPIATES SCREEN/CONTROL MODULE
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DJG
1996-10-30
CEDIA DAU OPIATE 2K ASSAY
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DJG
1996-03-06
FRONTLINE OPIATES
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DJG
1995-08-17
ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE)
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DJG
1995-07-14
OPIATES MICRO-PLATE ASSAY
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DJG
1995-05-18
AXSYM OPIATES
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DJG
1995-04-05
URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE
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DJG
1995-02-10
ABUSIGN(TM) OPI, DOA-OPI, ACCUSIGN(TM) OPI, DOA-OPI, BIOSIGN(TM) OPI, DOA-OPI
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DJG
1995-01-30
VISUALINE II MORPHINE/OPIATES/HEROIN
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DJG
1995-01-17
CEDIA DAU OPIATE ASSAY
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DJG
1994-11-30
CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS
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DJG
1994-11-17
VERDICT OPIATES
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DJG
1994-11-02
SOLOR CARE TECHNOLOGIES CORPORATION OPIATES
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DJG
1994-09-07
CEDIA DAU OPIATE ASSAY
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DJG
1994-01-11
CEDIA(R) DAU OPIATE ASSAY
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DJG
1994-01-06
EMIT(R) IIC OPIATE ASSAY
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DJG
1993-06-15
USDT OPIATE ASSAY COLUMN CATALOG NO. 9000-200
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DJG
1992-10-15
MICRO-PLATE OPIATES ASSAY
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DJG
1992-09-15
MICRO EIA FOR OPIATE METABOLITES
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DJG
1992-08-20
STC DIAGNOSTICS AUTO-LYTE OPIATE EIA
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DJG
1992-01-22
OPIATE EIA ASSAY
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DJG
1991-11-07
IL TEST(TM) OPIATE
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DJG
1991-09-19
URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
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DJG
1991-03-13
MICROLINE SCREEN FOR OPIATES
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DJG
1990-12-27
ABUSCREEN ONLINE TM FOR OPIATES
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DJG
1990-09-14
BIOSITE DIAGNOSTICS OPIATE SCREENING TEST
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DJG
1990-07-27
EMIT(R) II OPIATE ASSAY
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DJG
1990-07-17
MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT
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DJG
1990-05-17
MILENIA(TM) OPIATES
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DJG
1990-03-30
HYCOR ACCUPINCH MORPHINE TEST
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DJG
1990-03-09
EZ-SCREEN:OPIATES
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DJG
1989-11-17
TARGET OPIATES-R
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DJG
1989-10-04
TARGET OPIATES-V
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DJG
1989-09-28
COAT-A-COUNT(TM) FENTANYL (TKFN1)
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DJG
1989-03-15
ABUSCREEN FP FOR MORPHINE
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DJG
1988-09-02
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE
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DJG
1988-08-02
EMIT HVA OPIATE ASSAY
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DJG
1988-02-18
COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5
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DJG
1988-02-11
REVISED LABELING FOR ADX OPIATES
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DJG
1987-11-23
REVISED LABELING FOR OPIATES
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DJG
1987-11-13
REVISED LABELING FOR MORPHINE TEST KIT
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DJG
1987-10-29
REVISED LABELING FOR SYVA OPIATE ASSAYS
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DJG
1987-10-15
LABELING CHANGE COAT-A-COUNT SERUM MORPHINE
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DJG
1987-10-15
LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE
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DJG
1987-08-10
ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD
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DJG
1987-06-15
RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]
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DJG
1985-11-25
TDX R OPIATES
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DJG
1984-09-26
EMIT D.A.U. OPIATE ASSAY
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DJG
1984-09-14
EMIT 700 OPIATE ASSAY
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DJG
1984-01-26
MODIF. OF EMIT URINE OPIATE ASSAY
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