Calibrators, Drug Mixture
FDA product code DKB · 92 cleared devices
Class 2
Clinical Toxicology
- Regulation
- 21 CFR 862.3200
- Review panel
- TX
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1979-05-03 – 2012-12-13
DKB
2012-12-13
DKB
2011-05-09
RANDOX METHAMPHETAMINE ASSAY
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DKB
2011-04-08
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
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DKB
2009-06-18
ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
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DKB
2009-06-01
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
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DKB
2006-09-14
DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
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DKB
2006-08-25
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420)
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DKB
2006-05-30
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
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DKB
2005-06-24
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
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DKB
2004-02-27
VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
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DKB
2003-12-15
PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
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DKB
2003-10-06
DIMENSION DRUG CALIBRATOR II, MODEL DC49C
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DKB
2003-08-06
PRECISET TDM I AND PRECISET TDM II CALIBRATORS
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DKB
2003-08-05
PRECISET DAT PLUS I CALIBRATORS
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DKB
2002-06-13
PRECISET DAT PLUS
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DKB
2002-01-29
BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS
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DKB
2001-09-12
RANDOX THERAPEUTIC DRUG CALIBRATOR
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DKB
2000-01-11
SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS
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DKB
1999-12-21
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
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DKB
1999-02-16
DIMENSION DRUG CALIBRATOR II, MODEL DC49B
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DKB
1998-12-30
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II
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DKB
1998-11-05
DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS
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DKB
1998-11-04
SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I
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DKB
1998-10-13
DRUG CALIBRATOR II
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DKB
1998-05-08
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
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DKB
1998-04-21
CEDIA DAU MULTI-DRUG CALIBRATORS
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DKB
1998-01-22
REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
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DKB
1997-06-25
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
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DKB
1997-05-08
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
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DKB
1996-09-16
DRUG CALIBRATOR II
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DKB
1996-09-10
CEDIA ANTIBIOTIC TDM MULTI-CALS
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DKB
1996-05-15
AED CALIBRATORS
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DKB
1996-05-01
SERUM TOX CALIBRATOR
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DKB
1995-12-26
CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
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DKB
1995-03-24
EMIT IIC CALIBRATORS
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DKB
1995-02-22
DRUGS OF ABUSE CALIBRATOR
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DKB
1994-12-13
DOA - IMMUNOASSAY CUT-OFF CALIBRATOR
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DKB
1994-10-04
ROCHE AMMONIA (VARIOUS)
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DKB
1994-07-06
URINE CALIBRATOR
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DKB
1994-03-14
CEDIA(R) DAU BAR/BENZ 300,300 INTERMED & HIGH CALIB
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DKB
1994-03-14
CEDIA DAU NEGATIVE CALIBRATOR
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DKB
1994-01-27
URINE CALIBRATORS AND CONTROLS MODIFICATION
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DKB
1994-01-25
CEDIA DAU 4-DRUG CUTOFF CALIBRATOR
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DKB
1994-01-25
CEDIA DAU 5-DRUG CALIBRATORS
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DKB
1994-01-03
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
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DKB
1993-08-03
ABUSCREEN ONLINE(R) CALIBRATORS
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DKB
1993-07-22
ABUSCREEN CALIBRATION STANDARD
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DKB
1993-07-22
ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
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DKB
1992-08-04
ROCHE ABUSCREEN ONLINNE CALIBRATORS
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DKB
1992-03-04
URINE A CALIBRATOR
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DKB
1991-11-29
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
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DKB
1991-10-21
IL TEST(TM) DAT CAL/CONTROL SET C
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DKB
1991-10-21
IL TEST(TM) DAT CAL/CONTROL SET B
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DKB
1991-09-13
CONTROL AND LINEARITY
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DKB
1991-09-10
IL TEST(TM) DAT CALIBRATOR A( -)
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DKB
1991-08-26
ABUSCREEN(R) ONLINE(TM) CALIBRATORS
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DKB
1991-07-22
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
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DKB
1991-03-11
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
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DKB
1991-02-04
ABUSCREEN ONLINE OPIATES CALIBRATORS
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DKB
1991-02-04
ABUSCREEN(R) ONLINE CALIBRATORS
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DKB
1990-11-20
EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)
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DKB
1990-08-17
EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS
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DKB
1990-07-27
EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
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DKB
1990-07-10
EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2
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DKB
1990-06-06
EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B
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DKB
1989-10-17
HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS
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DKB
1989-07-25
HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS
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DKB
1989-05-11
DRUGS OF ABUSE URINE CALIBRATORS
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DKB
1989-02-17
DRUG STANDARD SET
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DKB
1988-09-09
URINE TOXICOLOGY STANDARD
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DKB
1988-07-08
EMIT HVA CALIBRATOR KIT
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DKB
1988-06-22
HIGH PERFORMANCE CALIBRATORS
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DKB
1988-05-31
THERAPEUTIC DRUG STANDARD
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DKB
1987-09-14
ACA URINE DRUGS OF ABUSE CALIBRATOR
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DKB
1987-06-11
4-9295 BARBITURATES TEST MIX
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DKB
1986-07-11
EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95
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DKB
1984-09-26
EMIT 700 CALIBRATOR B
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DKB
1984-09-12
EMIT 700 CALIBRATOR A
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DKB
1984-09-05
EMIT D.A.U. LOW & MED. CALIBRATORS B
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DKB
1984-08-15
ACA BARBITURATES SCREEN/BENZODIAZEPIN
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DKB
1984-02-03
LIQUI-SERA TDM CALIBRATORS
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DKB
1984-01-13
THERAPEUTIC DRUG CONTROL
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DKB
1984-01-01
DRUG STANDARDS
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DKB
1983-01-05
ADVANCE SYSTEM EMITAED ANTIEPILEPTIC
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DKB
1982-06-25
EMIT ST URINE METHAGUALONE CALIBRATOR
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DKB
1982-03-11
EMIT-ST URINE CALIBRATOR A (#3A319
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DKB
1982-02-12
CALIBRATOR SET
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DKB
1981-07-15
DRUG STANDARDS
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DKB
1981-06-25
EMIT-TOX SERUM CALIBRATORS
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DKB
1981-03-06
EMIT-ST SERUM CALBRATOR
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DKB
1980-11-12
EMIT-STM URINE CALIBRATORS
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DKB
1979-05-03
EMIT-TOX SERUM CALIBRATORS
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