Calibrator, Secondary
FDA product code JIT · 231 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
- 1976-10-05 – 2017-05-16
JIT
2001-09-11
JIT
2001-08-24
MODIFICATION TO ELECSYS FSH II CALSET
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JIT
2001-08-01
WAKO IMMUNOASSAY CALIBRATOR SET
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JIT
2001-06-25
WAKO LIPID CALIBRATOR
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JIT
2001-05-02
RAICHEM CREATININE URINE STANDARD
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JIT
2001-04-20
DIMENSION CTNI CALIBRATOR
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JIT
2001-03-15
N PROTEIN STANDARD UY CALIBRATOR
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JIT
2001-03-01
ELECSYS TESTOSTERONE CALSET II
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JIT
2001-02-20
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
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JIT
2001-01-26
ELECSYS FSH CALSET II
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JIT
2000-11-30
FASTPACK CALIBRATORS
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JIT
2000-11-20
ACCESS ULTRASENSITIVE HGH CALIBRATORS
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JIT
2000-05-04
DIRECT TIBC CALIBRATOR
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JIT
2000-03-01
DIMENSION SPECIAL PROTEIN CALIBRATOR
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JIT
1999-10-04
GENZYME DIRECT AMYLASE VERIFIER
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JIT
1999-09-24
ELECSYS ESTRADIOL CALSET II
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JIT
1999-07-15
N PROTEIN STANDARD UY
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JIT
1999-07-01
OPUS TROPONIN I CALIBRATOR
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JIT
1999-04-16
REVISED C-REACTIVE PROTEIN CALIBRATOR
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JIT
1999-03-22
DIMENSION SPECIAL PROTEIN CALIBRATOR
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JIT
1998-12-14
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR
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JIT
1998-11-18
DIMENSION AHDL CALIBRATOR
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JIT
1998-11-04
STRATUS CS TROPONIN I CALIBRATOR
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JIT
1998-11-04
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
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JIT
1998-10-27
FERRITIN CALIBRATOR
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JIT
1998-08-18
OLYMPUS SERUM PROTEIN MULTICALIBRATOR,
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JIT
1998-08-13
PREALBUMIN CALIBRATOR
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JIT
1998-04-16
STRATUS CS TROP CALPAK
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JIT
1998-04-16
STRATUS CS CKMB CALPAK
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JIT
1998-04-15
STRATUS CS MYO CALPAK
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JIT
1997-10-20
CARDIAC TROPONIN-I (TROP) CALIBRATOR
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JIT
1997-09-29
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR
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JIT
1997-06-16
ELECSYS CEA ASSAY
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JIT
1997-03-03
MMB CALIBRATOR
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JIT
1997-02-18
THYROID CALIBRATOR
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JIT
1996-12-03
FERRITIN CALIBRATOR
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JIT
1996-08-15
ACA PLUS FT4 CALIBRATOR
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JIT
1996-07-23
STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY
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JIT
1995-08-31
DUPONT LIPASE CALIBRATOR
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JIT
1994-11-02
FLUIDS PACK
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JIT
1994-09-14
LIPASE CALIBRATOR
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JIT
1994-03-11
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR
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JIT
1991-11-08
TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL
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JIT
1991-03-29
CHOLESTEROL CALIBRATOR SET
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JIT
1991-02-27
ELECTROPHORESIS CONTROL
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JIT
1990-11-28
SECONDARY CALIBRATORS
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JIT
1990-01-18
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
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JIT
1990-01-18
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
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JIT
1989-10-31
OSMOMETER STANDARD SOLUTIONS
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JIT
1989-08-15
CHLORIDE STANDARDS ITEM #SR1041
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JIT
1989-07-20
DOCUMENT(TM) URIC ACID LINEARITY TEST SET
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JIT
1988-12-14
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
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JIT
1988-10-25
BILIRUBIN STANDARD
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JIT
1988-10-06
BINAS LUTEINIZING HORMONE IRMA TEST KIT
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JIT
1988-07-21
DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023
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JIT
1987-12-14
PARAMAX ISE CHLORIDE CALIBRATOR
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JIT
1987-09-29
G-GT STANDARD CALIBRATOR
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JIT
1987-09-11
BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052
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JIT
1987-08-21
BILE ACIDS CALIBRATOR
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JIT
1987-07-22
TOTAL BILIRUBIN STANDARD CALIBRATOR
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JIT
1987-05-27
CREATININE STANDARD SOLUTION CALIBRATOR
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JIT
1987-05-26
URIC ACID STANDARD SOLUTION CALIBRATOR
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JIT
1987-05-26
UREA N STANDARD SOLUTION CALIBRATOR
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JIT
1987-05-26
TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR
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JIT
1987-05-26
PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR
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JIT
1987-05-26
INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR
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JIT
1987-05-26
NEFA STANDARD SOLUTION CALIBRATOR
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JIT
1987-05-26
MAGNESIUM STANDARD SOLUTION CALIBRATOR
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JIT
1987-05-26
GLUCOSE STANDARD SOLUTION CALIBRATOR
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JIT
1987-05-26
ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8
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JIT
1987-03-19
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR
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JIT
1986-08-19
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
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JIT
1986-07-01
CHOLESTEROL CALIBRATORS
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JIT
1985-12-19
ABSORBANCE (ABS) TEST PAK
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JIT
1985-09-30
LIQUI-SERA CHEM. MULTIPLE CALIBRATORS
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JIT
1985-09-16
ABSORBANCE TEST SOLUTION
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JIT
1985-07-12
CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET
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JIT
1985-05-31
DIRECT BILIRUBEN CALIBRATIONS
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JIT
1985-05-10
CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/
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JIT
1984-12-11
TRIGLYCERIDE CALIBRATOR
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JIT
1984-11-09
FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS
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JIT
1984-09-13
ROCHE STANDARDS FOR URIC ACID
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JIT
1984-08-17
ACTH STANDARD MATRIX
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JIT
1984-04-13
ALCOHOL & AMMONIA CALIBRATOR II
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JIT
1984-04-13
ALCOHOL & AMMONIA CALIBRATOR I
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JIT
1984-04-04
CARBON DIOXIDE CALIBRATOR II
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JIT
1984-04-04
CARBON DIOXIDE CALIBRATOR I
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JIT
1984-03-23
TRIGLYCERIDE AQUEOUS STANDARDS
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JIT
1984-01-04
ACA THYROXINE UPTAKE CALIBRATOR
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JIT
1983-12-27
ACA THYROXINE CALIBRATOR
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JIT
1983-08-11
BILIRUBIN CALIBRATORS & CONTROL
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JIT
1983-03-24
BILIRUBIN STANDARD-LYOPHILIZED
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JIT
1982-11-16
KM - KAL 2
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JIT
1982-11-16
KM - KAL 1
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JIT
1982-11-16
KM-KAL L6
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JIT
1982-11-16
KM-KAL 6
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JIT
1982-11-16
KM - KAL 5
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JIT
1982-11-16
KM-KAL 4
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JIT
1982-11-16
KM-KAL 3
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JIT
1982-10-27
TRIGLYCERIDE CALIBRATOR
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