Single (Specified) Analyte Controls (Assayed And Unassayed)
FDA product code JJX · 460 cleared devices
Class 1
Clinical Chemistry
- Regulation
- 21 CFR 862.1660
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-10-29 – 2017-04-04
JJX
2000-04-05
JJX
2000-03-17
ELECSYS B-CROSSLAPS CALCHECK
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JJX
2000-03-02
TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
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JJX
2000-02-29
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS
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JJX
2000-02-28
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
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JJX
2000-02-24
BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS
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JJX
2000-01-18
ACCESS HYBRITECH PSA QC, MODEL 37209
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JJX
2000-01-14
ACCESS OSTASE QC
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JJX
2000-01-05
ACCESS HYBRITECH FREE PSA QC, MODEL 37219
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JJX
1999-11-30
ELECSYS PARATHYROID HORMONE CALCHECK
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JJX
1999-11-26
TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION
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JJX
1999-05-10
ATLAST GLUCOSE CONTROL SOLUTION
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JJX
1999-04-08
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS
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JJX
1999-03-30
ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05
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JJX
1999-03-25
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS
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JJX
1999-03-22
ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05
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JJX
1999-03-19
SAS HCG URINE CONTROLS
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JJX
1999-03-19
SAS HCG SERUM CONTROLS
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JJX
1999-02-02
ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05
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JJX
1999-02-02
ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05
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JJX
1999-01-29
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE VERIFIERS, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS
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JJX
1999-01-29
ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5
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JJX
1999-01-28
ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
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JJX
1999-01-25
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS
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JJX
1998-12-22
ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05
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JJX
1998-12-22
ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05
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JJX
1998-12-17
SUPREME II CONTROL SOLUTIONS
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JJX
1998-12-15
ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
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JJX
1998-12-15
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05
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JJX
1998-12-15
ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05
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JJX
1998-12-07
VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS
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JJX
1998-12-03
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644
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JJX
1998-11-25
ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
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JJX
1998-11-25
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
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JJX
1998-11-24
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
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JJX
1998-11-18
CARDIAC MARKER CONTROL MODULE, MODEL CCCM
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JJX
1998-11-12
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
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JJX
1998-08-06
B2-MICROGLOBULIN CONTROL SET SERUM
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JJX
1998-08-05
DADE TRU-LIQUID CARDIAC CONTROL
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JJX
1998-07-06
VIGIL HEMOGLOBIN (HBALC) CONTROLS
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JJX
1998-06-12
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
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JJX
1998-06-08
DADE TRU-LIQUID CARDIAC CONTROL
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JJX
1998-04-24
ELECSYS CALCHECK FERRITIN
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JJX
1998-04-23
ELECSYS CALCHECK CA 125II
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JJX
1998-02-10
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL
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JJX
1998-01-13
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
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JJX
1998-01-06
REP CHOLESTEROL PROFILE CONTROL-II
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JJX
1997-12-16
PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH
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JJX
1997-12-15
ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH
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JJX
1997-12-15
DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH
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JJX
1997-12-08
ELECSYS CALCHECK VITAMIN B12
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JJX
1997-11-26
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
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JJX
1997-10-27
OPUS HLH CONTROLS
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JJX
1997-10-06
MYOGLOBIN CONTROL SET
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JJX
1997-09-29
PROSTATE SPECIFIC ANTIGEN CONTROL
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JJX
1997-09-12
WAKO NEFA LINEARITY SET
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JJX
1997-08-06
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
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JJX
1997-07-28
CARDIAC STATUS CONTROLS/TROPONIN I
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JJX
1997-07-07
DADE TRU-LIQUID BILIRUBIN CONTROL
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JJX
1997-04-23
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS
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JJX
1997-04-17
LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
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JJX
1997-04-10
IMMULITE THYROID AUTOANTIBODY CONTROL MODULE
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JJX
1997-04-02
THE ELECSYS CALCHECK PROGESTERONE
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JJX
1997-03-06
ELECSYS CALCHECK CEA
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JJX
1997-03-06
ELECSYS CALCHECK PSA
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JJX
1997-03-06
ELECSYS CALCHECK CEA
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JJX
1997-03-03
ABBOTT HCG SERUM CONTROLS
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JJX
1997-02-10
ELECSYS CALCHECK ESTRADIOL
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JJX
1997-02-06
HCG CONTROLS
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JJX
1997-01-30
ELECSYS CALCHECK TESTOSTERONE
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JJX
1996-12-16
ELECSYS CALCHECK LH
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JJX
1996-11-22
WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6
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JJX
1996-11-08
HEMOCUE GLUCOLIN
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JJX
1996-11-01
HEMOCUE GLUCOTROL
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JJX
1996-10-28
RADIAS GALT TEST
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JJX
1996-10-07
BIO-CSF LIQUID CONTROL LEVEL 1 AND 2
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JJX
1996-09-10
ELECSYS CALCHECK T UPDATE
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JJX
1996-08-30
ELECSYS CALCHECK HCG
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JJX
1996-08-29
IMMULITE ACTH CONTROL MODULE (LACCM)
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JJX
1996-08-29
PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)
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JJX
1996-08-27
ELECSYS CALCHECK T4
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JJX
1996-08-27
ELECYS CALCHECK T 3
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JJX
1996-08-27
ELECSYS CALCHECK FT4
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JJX
1996-08-27
ELECSYS CALCHECK FT3
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JJX
1996-08-23
ELECSYS CALCHECK CK-MB
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JJX
1996-08-23
ELECSYS CALCHECK TSH
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JJX
1996-08-23
ELECSYS CALCHECK TROPONIN T
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JJX
1996-08-20
LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III
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JJX
1996-08-15
OPUS MYOGLOBIN CONTROLS
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JJX
1996-07-22
OPUS B12 CONTROLS
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JJX
1996-07-22
ELECSYS PRECICONTROL TSH
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JJX
1996-07-05
LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
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JJX
1996-06-17
ACS FRT4 IMMUNOASSAY
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JJX
1996-06-14
COMPLEMENT CONTROL
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JJX
1996-04-23
OPUS T3 CONTROLS
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JJX
1996-04-03
ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS
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JJX
1996-03-20
LXN FRUCTOSAMINE TEST
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JJX
1996-03-13
PSA CONTROLS
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JJX
1996-02-29
IRON CALIBRATOR & CALIBRATION VERIFICATION SET
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JJX
1996-02-23
OPUS PROLACTIN CONTROLS
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