Enzyme Immunoassay, Amphetamine
FDA product code DKZ · 212 cleared devices
Class 2
Clinical Toxicology
- Regulation
- 21 CFR 862.3100
- Review panel
- TX
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-08-03 – 2024-10-30
DKZ
2001-04-05
DKZ
2001-03-30
AT HOME DRUG TEST, MODEL 9063 T
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DKZ
2001-03-08
MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12
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DKZ
2001-02-28
COBAS INTEGRA AMPHETAMINES
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DKZ
2000-11-22
BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST
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DKZ
2000-11-16
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL
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DKZ
2000-08-07
INSTANT-VIEW AMPHETAMINE URINE CASSETTE TEST
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DKZ
2000-08-04
INSTANT-VIEW AMPHETAMINE URINE DIP STRIP TEST
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DKZ
2000-07-12
ONTRAK TESTCUP 501, MODEL 3016633
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DKZ
2000-06-29
ONTRAK TESTCUP 502, MODEL 3016641
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DKZ
2000-05-26
QUICKSCREEN PRO DRUG CUP, MODEL 9195X
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DKZ
2000-05-17
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
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DKZ
2000-05-05
SYNCHRON SYSTEMS AMPHETAMINE REAGENT
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DKZ
2000-05-02
CEDIA DAU AMPHASSURE ASSAY
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DKZ
2000-04-18
SCREENERS AMPHETAMINE TEST, DRUGSCREEN DIP AMPHETAMINE TEST
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DKZ
2000-04-14
URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
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DKZ
2000-04-03
STC AMPHETAMINE-SPECIFIC INTERCEPT MICRO-PLATE EIA, MODEL 1103I
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DKZ
2000-01-27
IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5
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DKZ
1999-12-30
AT HOME DRUG TEST, MODEL 9063
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DKZ
1999-07-15
DBSET MULTIDRUG SCREEN TEST KIT
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DKZ
1999-06-30
MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
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DKZ
1999-06-24
QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
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DKZ
1999-04-15
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
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DKZ
1999-04-13
ONTRAK TESTCUP-ER M2K
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DKZ
1999-02-26
RAPID DRUG SCREEN 5-PANEL WITH METHAMPHETAMINE TEST
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DKZ
1999-02-23
ONTRAK TESTCUP-5 M2K
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DKZ
1998-12-31
'RAPID DRUG SCREEN' 9-PANEL
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DKZ
1998-12-11
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
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DKZ
1998-08-27
'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME
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DKZ
1998-08-06
DBEST AMPHETAMINES TEST KIT
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DKZ
1998-06-16
ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST
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DKZ
1998-04-01
QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147, 9061,9066, 9071, 9076, 9081 AND 9131
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DKZ
1998-03-20
MICRO-STRIP FOR AMPHETAMINE METABOLITES
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DKZ
1998-01-28
STC METHAMPHETAMINE MICRO-PLATE EIA
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DKZ
1997-12-03
TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS
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DKZ
1997-11-06
FINGERPRINT DRUG SCREENING DEVICE
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DKZ
1997-10-09
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON
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DKZ
1997-10-01
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
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DKZ
1997-08-12
VISUALINE II METHAMPHETIMINE
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DKZ
1997-06-26
QUIKSTRIP ONE STEP METHAMPHETAMINE
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DKZ
1997-05-30
QUIKSTRIP ONE STEP AMPHETAMINE TEST
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DKZ
1997-05-14
QUIKPAC II ONE STEP AMPHETAMINE TEST
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DKZ
1997-05-13
QUICKPAC II ONE STEP METHAMPHETAMINE TEST
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DKZ
1997-04-08
ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST
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DKZ
1996-10-07
ONTRAK TESTCUP AMPHETAMINES
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DKZ
1996-02-16
TRIAGE PANEL FOR DRUGS OF ABUSE MODEL 9500/93000
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DKZ
1996-02-15
TRIAGE PANEL FOR DRUGS OF ABUSE/TRICYCLIC ANTIDEPRESSANTS
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DKZ
1995-10-06
AXSYM AMPHETAMINE/METHAMPHETAMINE II
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DKZ
1995-07-14
AMPHETAMINES MICRO-PLATE EIA
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DKZ
1995-05-08
CEDIA DAU AMPHETAMINES ASSAY
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DKZ
1995-05-01
FINGERPRINT-DOA
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DKZ
1995-04-13
ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP
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DKZ
1995-03-30
URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE
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DKZ
1995-02-22
ABUSIGN DOA4
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DKZ
1995-02-22
EMIT(R) IIC AMPHETAMINE ASSAY
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DKZ
1994-12-07
CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS
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DKZ
1994-10-21
CEDIA DAU AMPHETAMINES ASSAY
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DKZ
1994-09-16
MICROLINE SCREEN FOR AMPHETAMINE
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DKZ
1994-07-20
CEDIA DAU AMPHETAMINES ASSAY
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DKZ
1994-01-25
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
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DKZ
1994-01-13
AMPHETAMINES EIA ASSAY MODIFICATION
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DKZ
1993-12-07
MICRO EIA FOR AMPHETAMINE METABOLITES
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DKZ
1993-11-22
AMPHETAMINE TEST SYSTEM
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DKZ
1993-09-15
ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED
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DKZ
1993-07-20
SOLARCARE TECHNOLOGIES CORP. MICROPLATE AMP. ASSAY
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DKZ
1993-04-16
STC DIAGNOSTICS AUTO-LYTE AMPHETAMINES EIA
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DKZ
1993-01-22
THE TRIAGE II
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DKZ
1992-05-26
ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED
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DKZ
1992-05-04
AMPHETAMINES EIA TEST
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DKZ
1992-03-19
ACCUSCREEN ASSAY
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DKZ
1992-02-27
EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY
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DKZ
1991-11-07
IL TEST(TM) AMPHETAMINE
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DKZ
1991-10-11
BIOSITE DIAGNOSTICS-TRIAGE PANEL FOR DRUGS ABUSE
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DKZ
1991-07-26
ABUSCREEN ONLINE FOR AMPHETAMINES
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DKZ
1991-04-03
ABUSCREEN ONTRAK FOR METHAMPHETAMINE
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DKZ
1991-04-03
ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML)
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DKZ
1991-03-21
TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH)
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DKZ
1991-03-19
TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)
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DKZ
1991-03-11
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
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DKZ
1991-01-15
EZ-SCREEN: AMPHETAMINES
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DKZ
1990-12-20
MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT
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DKZ
1990-11-28
HYCOR ACCUPINCH METHAMPHETAMINE TEST
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DKZ
1990-11-21
MILENIA (TM) METHAMPHETAMINE
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DKZ
1990-09-27
DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY
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DKZ
1990-09-07
MILENIA (TM) AMPHETAMINE
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DKZ
1990-04-20
EMIT D.A.U. AMPHETAMINE CLASS ASSAY
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DKZ
1990-03-09
ABUSCREEN FP FOR METHAMPHETAMINE
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DKZ
1989-09-25
LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II
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DKZ
1989-08-25
ADX AMPHETAMINE/METHAMPHEAMINE
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DKZ
1989-08-15
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
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DKZ
1989-08-11
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
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DKZ
1989-03-10
ABUSCREEN FP FOR AMPHETAMINE
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DKZ
1988-10-20
TDX AMPHETAMINE/METHAMPHETAMINE II
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DKZ
1988-10-11
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
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DKZ
1988-08-02
EMIT HVA AMPHETAMINE ASSAY
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DKZ
1988-04-21
TDX (R) AMPHETAMINE CLASS
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DKZ
1988-03-01
REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA.
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DKZ
1988-02-16
ABUSCREEN(R) EIA AMPHETAMINE
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DKZ
1987-11-23
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA.
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DKZ
1987-11-13
REVISED LABELING FOR AMPHETAMINE TEST KIT
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