Enzymatic Method, Creatinine
FDA product code JFY · 47 cleared devices
Class 2
Clinical Chemistry
- Regulation
- 21 CFR 862.1225
- Review panel
- CH
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1981-08-31 – 2026-02-20
JFY
2026-02-20
JFY
2021-11-24
Atellica CH Enzymatic Creatinine_3 (ECre3)
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JFY
2021-05-10
Yumizen C1200 Creatinine PAP
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JFY
2019-07-26
ACR LAB Urine Analysis Test System
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JFY
2019-02-16
GEM Premier ChemSTAT
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JFY
2018-12-10
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
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JFY
2018-10-30
VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
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JFY
2017-07-21
Teco Creatinine Enzymatic Reagent Kit
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JFY
2016-03-07
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
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JFY
2011-11-18
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
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JFY
2011-08-10
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
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JFY
2009-12-04
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
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JFY
2009-08-14
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
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JFY
2009-05-22
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
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JFY
2008-06-30
S-TEST CREATININE (CRE)
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JFY
2008-06-19
MULTIGENT CREATININE (ENZYMATIC) ASSAY
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JFY
2008-02-12
AFINION ACR AND ACR CONTROL
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JFY
2008-01-03
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
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JFY
2007-12-03
CREATININE (ENZYMATIC)
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JFY
2007-08-03
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
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JFY
2007-06-22
ENZYMATIC CREATININE ASSAY (265 SERIES)
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JFY
2007-05-25
VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927
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JFY
2007-05-25
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
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JFY
2007-04-23
DIAZYME CREATININE LIQUID REAGENTS ASSAY
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JFY
2007-03-23
THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
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JFY
2007-02-23
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
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JFY
2006-12-15
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
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JFY
2006-11-03
POLY-CHEM CREATININE
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JFY
2005-06-30
CREATININE LIQUICOLOR
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JFY
2003-06-25
IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
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JFY
2002-12-19
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
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JFY
2002-07-05
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
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JFY
2001-10-10
WIENER LAB. CREATININA CINETICA AA
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JFY
2001-06-20
BIOSCANNER CREATININE TEST STRIPS
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JFY
2000-11-16
CREATININE PLUS
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JFY
2000-05-05
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
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JFY
1999-08-10
DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
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JFY
1998-03-30
CARESIDE CREATININE
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JFY
1991-10-31
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
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JFY
1991-08-12
REFLOTRON CREATININE TEST TABS
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JFY
1990-09-07
REFLOTRON CREATININE TEST TABS
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JFY
1988-02-24
KODAK EKTACHEM DT SLIDES (CRSC)
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JFY
1987-02-12
RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)
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JFY
1986-09-09
CREATININE-E
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JFY
1986-01-17
CREATININE PAP
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JFY
1984-05-01
CREATININE REAGENT SET
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JFY
1981-08-31
ENXYMATIC CREATININE TEST
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