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
2000-12-20
JJY
2000-11-27
SYNCHRON CONTROL
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JJY
2000-11-27
N/T PROTEIN CONTROL SL
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JJY
2000-11-02
QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3
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JJY
2000-08-31
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
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JJY
2000-08-22
DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3
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JJY
2000-08-07
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
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JJY
2000-07-05
DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)
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JJY
2000-06-19
OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
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JJY
2000-05-25
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
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JJY
2000-04-20
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
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JJY
2000-04-13
QUALITROL LIPID CONTROL, LEVELS 1 AND 2
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JJY
2000-03-07
ELECSYS CORTISOL TEST SYSTEM
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JJY
2000-02-15
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
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JJY
1999-12-20
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
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JJY
1999-12-09
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
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JJY
1999-12-09
QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3
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JJY
1999-11-30
TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3
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JJY
1999-11-30
APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
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JJY
1999-11-26
SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
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JJY
1999-11-26
MODIFICATION TO DOCUMENT THYROID CAL.VER
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JJY
1999-11-24
PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
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JJY
1999-11-24
PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
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JJY
1999-11-24
ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK
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JJY
1999-11-12
QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3
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JJY
1999-11-09
LYPHOCHEK ANEMIA CONTROL, MODEL 500
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JJY
1999-09-02
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580
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JJY
1999-08-24
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS
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JJY
1999-08-11
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
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JJY
1999-07-23
DOCUMENT THYROID CAL*VER
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JJY
1999-06-25
N/T PROTEIN CONTROL LC
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JJY
1999-06-11
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS
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JJY
1999-05-19
MODIFICATION OF N/T PROTEIN CONTROL SL
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JJY
1999-05-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS
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JJY
1999-04-27
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
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JJY
1999-04-07
MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
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JJY
1999-03-31
ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
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JJY
1999-03-18
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02
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JJY
1999-03-18
ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01
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JJY
1999-03-15
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01
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JJY
1999-03-12
VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS
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JJY
1999-03-09
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
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JJY
1999-02-02
LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220
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JJY
1999-02-02
ELECSYS IGE CALCHECK
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JJY
1999-01-29
LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529
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JJY
1999-01-28
ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01
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JJY
1999-01-26
ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01
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JJY
1999-01-26
ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01
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JJY
1999-01-25
ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10
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JJY
1998-12-17
ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05
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JJY
1998-12-16
LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580
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JJY
1998-12-14
ELECSYS CALCHECK TROPONIN T
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JJY
1998-12-14
LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384
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JJY
1998-11-20
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
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JJY
1998-11-04
VITROS IMMUNODIAGNOSTIC PRODUCTS TESTOSTERONE ASSAY
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JJY
1998-11-03
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
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JJY
1998-10-09
BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC
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JJY
1998-09-29
ASO/CRP/RF CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
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JJY
1998-09-29
LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS
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JJY
1998-09-22
ELECSYS CALCHECK MYOGLOBIN
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JJY
1998-08-12
IMMULITE PSA CONTROL MODULE, MODEL LPSCM
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JJY
1998-08-12
TUMOR MARKER CONTROL
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JJY
1998-07-22
CHEM-CHEX STAT (NEW)
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JJY
1998-07-09
VIGIL PROTEIN CONTROL
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JJY
1998-05-18
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
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JJY
1998-05-13
THIRD GENERATION PSA CONTROL MODULE
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JJY
1998-05-12
LYPHOCHEK IMMUNOASSAY PLUS CONTROL
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JJY
1998-05-07
CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
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JJY
1998-04-21
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
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JJY
1998-03-04
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002
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JJY
1998-02-20
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
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JJY
1998-02-12
OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY
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JJY
1998-01-27
VIROTROL III
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JJY
1998-01-22
BM PRECIPATH(R) HDL/LDL-C CONTROL
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JJY
1998-01-22
AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL
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JJY
1998-01-08
TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE
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JJY
1997-12-17
VIGIL LIPID CONTROL
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JJY
1997-12-08
ELECSYS CALCHECK FOLATE
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JJY
1997-10-29
IMMUSURE
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JJY
1997-10-14
ABC CALIBRATION VERIFIERS
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JJY
1997-10-14
ABC LINEARITY VERIFIERS
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JJY
1997-10-07
PRECINORM RF, PRECIPATH RF
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JJY
1997-09-25
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
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JJY
1997-09-25
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS
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JJY
1997-09-04
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)
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JJY
1997-08-28
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
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JJY
1997-08-12
PRECICONTROL TUMOR MARKER 1 AND 2
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JJY
1997-08-12
ACCURUN 117 HBEAG POSITIVE CONTROL
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JJY
1997-08-12
ACCURUN 121 HAV IGM POSITIVE CONTROL
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JJY
1997-08-07
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
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JJY
1997-08-07
ACCURUN 120 HAV IGG POSITIVE CONTROL
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JJY
1997-08-04
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
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JJY
1997-06-26
NICHOLS ADVANTAGE CHEMILUMINESCENCE TRI-LEVEL SPECIALTY CONTROLS
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JJY
1997-06-24
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
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JJY
1997-06-18
QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3
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JJY
1997-06-16
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
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JJY
1997-06-16
SPECIALITY URINE 1,2
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JJY
1997-06-11
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
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JJY
1997-04-23
LIQUID LIGAND 1,2,3
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JJY
1997-04-08
CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 5
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