Calibrator, Primary
FDA product code JIS · 130 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1150
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-10-21 – 2012-08-14
JIS
2012-08-14
JIS
2006-05-31
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
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JIS
2006-03-09
DIMENSION IRON CALIBRATOR
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JIS
2005-12-23
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
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JIS
2003-11-07
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
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JIS
2003-10-21
GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER
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JIS
2003-08-13
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
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JIS
2003-06-06
CALIBRATION PLASMA LMW HEPARIN
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JIS
2003-06-02
CRP (II) CALIBRATORS
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JIS
2003-04-11
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
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JIS
2002-11-05
RANDOX C-REACTIVE PROTEIN CALIBRATOR
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JIS
2002-09-27
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
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JIS
2001-11-09
N LP(A) STANDARD SY
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JIS
2001-10-16
THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
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JIS
2001-09-28
RANDOX LIPOPROTEIN
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JIS
2001-05-10
BECKMAN COULTER DNASE B CALIBRATOR
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JIS
2001-01-25
ELECSYS HCG STAT CLASET II
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JIS
2001-01-12
ELECSYS CA 125 II CALSET
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JIS
2000-10-05
ELECSYS DHEA-S CALSET
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JIS
2000-08-10
ELECSYS CA 15-3 CALCHECK
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JIS
2000-07-13
ELECSYS INSULIN CALSET
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JIS
2000-06-01
WAKO HDL-C/LDL-C CALIBRATOR
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JIS
2000-06-01
WAKO APOLIPOPROTEIN HIGH LEVEL CALIBRATOR
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JIS
2000-05-24
WAKO LIPASE CALIBRATOR
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JIS
2000-02-10
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
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JIS
2000-02-03
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR
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JIS
2000-02-03
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
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JIS
2000-01-20
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
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JIS
2000-01-12
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
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JIS
1999-12-22
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS
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JIS
1999-11-09
WAKO BILIRUBIN CALIBRATOR
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JIS
1998-12-21
SYNCHRON SYSTEMS LIPID CALIBRATOR
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JIS
1997-05-23
AUTO HDL CHOLESTEROL CALIBRATOR
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JIS
1996-12-24
WAKO DIRECT HDL-C
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JIS
1996-12-06
CLINICAL BLOOD GAS MIXTURES
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JIS
1995-12-28
BLOOD GAS MIXTURE
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JIS
1995-06-29
SYNCHRON ENZYME VALIDATOR SET
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JIS
1995-06-15
T-UPTAKE CALIBRATORS
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JIS
1995-05-17
IMX ESTRADIOL
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JIS
1994-11-21
CALIBRATORS
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JIS
1994-05-09
GLYCATED PROTEIN CALIBRATORS
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JIS
1994-03-11
URINARY ALBUMIN CALIBRATOR
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JIS
1993-08-25
KING SODIUM/POTASSIUM STANDARD MODIFIED
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JIS
1993-08-19
DC-LINEATE CAT. NO. SE-091
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JIS
1993-08-09
DU PONT ACA NEV/EEV VERIFIER
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JIS
1993-06-25
REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM
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JIS
1993-06-07
ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR
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JIS
1993-03-18
DC-UIBC-CAL
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JIS
1993-01-13
HDL-CHOLESTEROL STANDARD, MODIFICATION
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JIS
1992-09-23
DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR
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JIS
1992-09-09
DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR
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JIS
1992-08-12
DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO
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JIS
1992-08-03
BIOTROL BICARBONATE STANDARDS
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JIS
1992-05-26
THYROXINE CALIBRATOR KIT
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JIS
1992-04-17
KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD
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JIS
1991-05-06
BIOTROL PROTEIN MULTILEVEL STANDARDS
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JIS
1991-02-26
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI
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JIS
1991-02-13
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
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JIS
1990-03-29
MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD
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JIS
1989-11-14
QUANTIMETRIX BILIRUBIN CALIBRATORS
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JIS
1989-11-13
HI CHEM TRIGLYCERIDES CALIBRATOR E (88185)
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JIS
1988-11-29
ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.
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JIS
1988-08-29
RAICHEM(TM) BILIRUBIN STANDARD
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JIS
1988-06-07
TERUMO SENSIBEAD EIA PROGESTERONE KIT
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JIS
1987-09-18
CALCIUM CALIBRATOR
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JIS
1987-05-28
LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086
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JIS
1987-05-28
LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084
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JIS
1987-05-28
CESIUM DILUENT 1.5 MMOL CS/L #60087
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JIS
1987-05-28
LITHIUM INTERNAL STANDARD 1 MEQ/L #60085
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JIS
1987-02-26
ISE COMPENSATION SERA
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JIS
1986-08-19
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
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JIS
1986-08-19
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
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JIS
1986-06-25
TOBRAMYCIN (FPIA) CALIBRATOR KIT
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JIS
1986-06-25
PHENYTOIN (FPIA) CALIBRATOR KIT
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JIS
1986-06-25
GENTAMICIN (FPIA) CALIBRATOR KIT
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JIS
1986-06-25
THEOPHYLLINE (FPIA) CALIBRATOR KIT
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JIS
1986-01-22
SERALYZER TOTAL BILIRUBIN CALIBRATORS
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JIS
1985-05-31
TOTAL BILIRUBIN STANDARDS
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JIS
1984-12-12
80 MG/DL GLUCOSE CONTROL
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JIS
1984-11-20
CHLORIDE STANDARD
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JIS
1984-09-04
ROCHE STANDARDS FOR CHOLESTEROL
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JIS
1984-08-16
HICHEM ION 2/4 URINE RANGE CALIBRATOR
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JIS
1984-08-16
HICHEM ION 2/4 SERUM RANGE CALIBRATOR
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JIS
1984-06-25
DUPONT ACA MAGNESIUM CALIBRATOR
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JIS
1984-03-23
PH ELECTRODE CALIBRATING BUFFERS-BLOOD
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JIS
1984-03-23
HDL CHOLESTEROL AQUEOUS STANDARDS
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JIS
1984-03-23
CHOLESTEROL AQUEOUS STANDARD
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JIS
1983-08-24
PRECISET CHOLESTEROL HIGH PERFORM
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JIS
1983-02-28
LITHIUM DILUENT
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JIS
1983-02-07
CALIBRATOR A
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JIS
1982-11-22
URIC ACID STANDARD, 8MG/DL #65078
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JIS
1982-09-17
CREATININE STANDARD #65072
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JIS
1982-09-17
CALCIUM STANDARD, ITEM #65075
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JIS
1982-09-14
PHOSPHOROUS STANDARD #65073
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JIS
1982-09-14
CHOLESTEROL STANDARD #65077
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JIS
1982-08-16
C-REACTIVE PROTEIN TEST KIT
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JIS
1982-08-16
ACA URINARY PROTEIN CALIBRATOR
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JIS
1982-07-20
BIO-CAL OPERATION CHECK KIT
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JIS
1982-07-16
SYVA ADVANCE STANDARDIZATION KIT #3
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JIS
1982-07-16
SYVA ADVANCE STANDARDIZATION KIT #2
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