Multi-Analyte Controls, All Kinds (Assayed)
FDA product code JJY · 659 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
- 1976-11-05 – 2017-03-31
JJY
2005-04-27
JJY
2005-04-25
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR
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JJY
2005-03-25
VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS
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JJY
2005-03-24
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
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JJY
2005-03-18
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
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JJY
2005-01-07
LIQUID ASSAYED MULTIQUAL CONTROL
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JJY
2004-12-09
AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
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JJY
2004-12-07
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
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JJY
2004-11-18
QUIKREAD CRP CALIBRATOR SET
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JJY
2004-11-05
QUEST TUMOR MARKER CONTROL, MODEL 955
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JJY
2004-10-15
VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501
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JJY
2004-10-07
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
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JJY
2004-09-17
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05
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JJY
2004-09-14
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
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JJY
2004-09-09
RANDOX TRI LEVEL CARDIAC CONTROL
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JJY
2004-07-27
MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)
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JJY
2004-07-06
TRIAGE PROFILER S.O.B. CONTROLS AND S.O.B. CALIBRATION VERIFICATION CONTROLS
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JJY
2004-06-16
RANDOX IMMUNOASSAY CONTROL
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JJY
2004-05-27
MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
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JJY
2004-05-21
DOCUMENT SALICYLATE CAL VER
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JJY
2004-05-19
LIQUICHEK TORCH PLUS IGM CONTROL
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JJY
2004-04-28
NORMAL AND HYPERGAMMA CONTROL SERUM
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JJY
2004-04-28
MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
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JJY
2004-04-02
NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)
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JJY
2004-03-29
LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS
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JJY
2004-03-11
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
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JJY
2004-03-10
LIQUICHEK CARDIAC MARKER CONTROL LT
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JJY
2004-03-04
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
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JJY
2004-02-23
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
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JJY
2004-01-16
LIGAND PLUS CONTROL LEVEL 1-3
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JJY
2004-01-07
ELECSYS PRECICONTROL MULTIANALYTE
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JJY
2003-12-19
BAYER SPECIAL CHEMISTRY CONTROLS
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JJY
2003-12-02
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
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JJY
2003-10-21
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS
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JJY
2003-10-10
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS
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JJY
2003-09-09
AUDIT MICROCONTROLS MICROFD BNP CONTROL
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JJY
2003-09-05
N/T PROTEIN CONTROL
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JJY
2003-08-28
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
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JJY
2003-08-25
LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS
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JJY
2003-08-19
MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
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JJY
2003-08-06
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS
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JJY
2003-07-30
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
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JJY
2003-07-23
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
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JJY
2003-06-25
BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL
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JJY
2003-06-16
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
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JJY
2003-05-30
MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3
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JJY
2003-04-28
MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
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JJY
2003-04-09
BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL
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JJY
2003-03-26
CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL
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JJY
2003-03-19
WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553
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JJY
2003-03-14
MAS LIPID LEVEL 1 AND 2
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JJY
2003-03-13
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS
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JJY
2003-03-03
BAYER LIGAND PLUS 1, 2, 3 CONTROLS
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JJY
2003-01-28
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS
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JJY
2003-01-23
TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS
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JJY
2003-01-17
TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS
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JJY
2003-01-06
VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110
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JJY
2002-12-24
QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3
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JJY
2002-12-19
MAS CARDIOIMMUNE TL LOW LEVEL LIQUID ASSAYED CARDIAC MARKER CONTROL, DADE CARDIAC TL LOW LEVEL LIQUID ASSAYED CARDIAC MA
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JJY
2002-12-17
MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3
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JJY
2002-12-06
LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
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JJY
2002-11-22
VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109
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JJY
2002-10-17
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE
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JJY
2002-10-02
LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE
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JJY
2002-10-02
LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE
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JJY
2002-10-02
LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE
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JJY
2002-09-27
PH AND AMINES EXTERNAL CONTROL SET
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JJY
2002-09-17
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596
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JJY
2002-08-30
RANDOX LIPID CONTROL
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JJY
2002-08-21
PTS PANELS MULTI-CHEMISTRY CONTROLS
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JJY
2002-07-16
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
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JJY
2002-06-25
MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL
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JJY
2002-06-10
MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
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JJY
2002-04-12
LIQUICHEK URINE CHEMISTRY CONTROL
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JJY
2002-03-21
VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108
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JJY
2002-03-19
IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3
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JJY
2002-03-01
MODIFICATION TO VIGIL LIPID CONTROL
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JJY
2001-12-21
MODIFICATION TO MAS CARDIOLMMUNE TL; DADE CARDIAC TL
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JJY
2001-12-07
MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL
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JJY
2001-11-20
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE
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JJY
2001-11-20
VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007
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JJY
2001-10-16
MODIFICATION TO SYNCHRON CONTROL
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JJY
2001-09-04
MODIFICATION TO N/T PROTEIN CONTROL SL
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JJY
2001-08-30
LIQUISPX LIQUID LIPID CONTROL
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JJY
2001-08-29
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642
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JJY
2001-08-28
COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3
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JJY
2001-08-20
MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL
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JJY
2001-08-20
VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
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JJY
2001-08-20
VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003
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JJY
2001-08-20
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
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JJY
2001-08-20
VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001
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JJY
2001-07-17
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
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JJY
2001-07-12
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800
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JJY
2001-07-05
TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
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JJY
2001-06-26
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
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JJY
2001-06-18
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVELS 1, 2, 3
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JJY
2001-06-08
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL
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JJY
2001-05-18
HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3
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JJY
2001-03-05
VIGIL SEROLOGY CONTROL LEVEL C
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JJY
2001-02-28
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
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