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
1995-12-06
JJX
1995-11-14
ACCESS LOW LEVEL IGE CONTROLS
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JJX
1995-10-06
OPUS HCG CONTROLS
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JJX
1995-09-08
IMMULITE HCG HIGH LEVEL CONTROL MODULE
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JJX
1995-08-24
OPUS T4 CONTROLS
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JJX
1995-07-13
DADE STRATUS TROPONIN-I CONTROL
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JJX
1995-06-06
SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3
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JJX
1995-04-03
IMMULITE(R) TBG
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JJX
1995-03-30
REP CHOLESTEROL PROFILE CONTROL
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JJX
1995-03-20
CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL
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JJX
1995-02-08
LIQUISPEX(TM) URINE ETHANOL CONTROL
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JJX
1995-02-03
CHEMSPEX(TM) AMMONIA CONTROL
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JJX
1995-01-17
DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET
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JJX
1995-01-17
SAS QUANT HCG SERUM
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JJX
1994-11-30
DOCUMENT R AMMONIA/ETHANOL CONTROL
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JJX
1994-11-22
QUANTITATE URIC ACID VERIFIER SET
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JJX
1994-11-17
SAS QUANT HCG URINE
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JJX
1994-11-17
SERUM PROTEIN CONTROLS
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JJX
1994-11-15
DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET
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JJX
1994-09-09
TNT TROPONIN T
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JJX
1994-08-26
CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET
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JJX
1994-08-02
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
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JJX
1994-06-21
AXSYM LUTEINIZING HORMONE (LH)
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JJX
1994-06-13
GLUCOMETER ELITE LOW CONTROL
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JJX
1994-06-03
ASSURE URINE HCG CONTROL
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JJX
1994-04-26
GLYCATED PROTEIN CONTROLS
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JJX
1994-04-20
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
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JJX
1994-04-05
DOCUMENT(R) ZERO
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JJX
1994-03-22
SERUM AMMONIA CONTROL
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JJX
1994-02-17
REFRACTOMETRIC, TOTAL PROTEIN
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JJX
1994-01-27
P-AMYLASE CONTROL
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JJX
1993-12-29
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET
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JJX
1993-12-29
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET
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JJX
1993-12-02
B-HCG HUMAN SERUM CONTROLS
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JJX
1993-11-26
SPQ MALB CONTROL LEVEL II
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JJX
1993-10-28
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2
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JJX
1993-09-24
SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES
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JJX
1993-09-21
AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES
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JJX
1993-08-16
IMMULITE TSH THIRD GENERATION CONTROL
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JJX
1993-08-02
DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET
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JJX
1993-07-28
MULTI LEVEL CONTROL FOR CKMB ISOENSYME IN SYRUM
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JJX
1993-07-28
CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3
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JJX
1993-06-29
CANNABINOID URINE CONTROLS
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JJX
1993-06-22
QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)
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JJX
1993-05-14
AIA-PACK IGE CALIBRATION VERIFICATION TEST SET
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JJX
1993-04-22
LD-1 CONTROL-LEVEL 1 & 2
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JJX
1993-03-22
AUTOSTAT ANTI-DSDNA
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JJX
1993-03-04
AIA-PACK AFP CALIBRATION VERIFICATION TEST SET
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JJX
1993-02-18
NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
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JJX
1993-02-17
TANDEM-E IGE II CALIBRATION VERIFICATION SET
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JJX
1993-02-05
KODAK AMERLITE CK-MB CONTROL SERA LAN.4413
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JJX
1993-01-28
SUGAR CHEX LINEARITY FOR THE ONE TOUCH
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JJX
1993-01-26
REFRACTROL-SP
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JJX
1993-01-11
AIA-PACK PRL CALIBRATION VERIFICATION TEST SET
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JJX
1993-01-11
ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET
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JJX
1993-01-11
DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD
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JJX
1992-12-28
CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3
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JJX
1992-12-28
AIA-PACK HCG CALIBRATION VERIFICATION TEST SET
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JJX
1992-12-28
AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET
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JJX
1992-11-18
TSH - THIRD GENERATION LOW CONTROLS
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JJX
1992-11-16
AIA-PACK FSH CALIBRATION VERIFICATION TEST SET
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JJX
1992-11-16
AIA-PACK T-U CALIBRATION VERIFICATION TEST SET
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JJX
1992-11-16
AIA-PACK PAP CALIBRATION VERIFICATION TEST SET
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JJX
1992-11-05
DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET
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JJX
1992-11-05
DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET
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JJX
1992-11-05
DOCUMENT CHEM III CALIBRATION VERIFICATION TEST
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JJX
1992-08-12
LIPID CONTROLS
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JJX
1992-07-30
RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II
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JJX
1992-07-17
TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL
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JJX
1992-07-17
TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET
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JJX
1992-04-29
HCG CONTROL
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JJX
1992-04-29
LYPHOCHEK(R) FRUCTOSAMINE CONTROL
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JJX
1992-03-02
TSH CONTROL
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JJX
1992-01-30
MILENIA DATA REDUCTION
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JJX
1992-01-27
MP MINI PHOTOMETER
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JJX
1991-10-21
LIPASE LINEARITY CONTROL
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JJX
1991-09-25
HI CHEM LOW/MID/HIGH AQUEOUS GLUCOSE CONTROL
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JJX
1991-09-25
QUANTIMETRIX AMMONIA CONTROLS
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JJX
1991-09-11
CHOLINESTERASE LINEARITY CONTROL
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JJX
1991-08-28
TANDEM-E TSH CALIBRATION VERIFICATION CONTROL SET
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JJX
1991-05-31
DIRECTIGEN 1-2-3 PREGNANCY CONTROLS
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JJX
1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III
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JJX
1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II
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JJX
1991-05-01
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I
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JJX
1991-02-04
BIOTROL BILIRUBIN C & T CONTROL
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JJX
1990-11-02
SERACON CR REFERENCE
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JJX
1990-10-15
DUPONT DRUG CALIBRATOR-A
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JJX
1990-08-09
CHEM-CHEX-ALT
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JJX
1990-08-09
PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF
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JJX
1990-07-27
AMERSHAM TSH CONTROL SERA
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JJX
1990-07-16
CHEM-CHEX BILIRUBIN
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JJX
1990-05-30
ROTAG CONTROLS
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JJX
1990-02-26
POSITIVE AND NEGATIVE HCG SERUM CONTROLS
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JJX
1989-10-25
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104
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JJX
1989-10-23
MICRO-PLATE READER, MDX-1
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JJX
1989-09-28
SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)
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JJX
1989-09-05
RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL
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JJX
1989-08-31
POSITIVE AND NEGATIVE HCG URINE CONTROLS
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JJX
1989-08-01
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3
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JJX
1989-06-23
DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET
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