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Panels › Clinical Chemistry › Product code JFY · Class 2

Enzymatic Method, Creatinine

Regulation 862.1225

1510(k)s in 12 months (49 all time)
0recalls in 12 months (29 all time)
29recalls that name a 510(k)
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Top companies in JFY

DateFirm and productCodeLinked 510(k)
Jul 13, 2020Ortho-Clinical Diagnostics
VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
Terminated
JFYK182063
Jun 5, 2020Siemens Healthcare Diagnostics, Inc.
Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine
Terminated
JFYK090330
Jun 5, 2020Siemens Healthcare Diagnostics, Inc.
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for t
Terminated
JFYK073055
Jun 5, 2020Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine f
Terminated
JFYK070727
Jun 5, 2020Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and uri
Terminated
JFYK070727
Jan 24, 2020Siemens Healthcare Diagnostics, Inc.
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Terminated
JFYK090330
Jan 24, 2020Siemens Healthcare Diagnostics, Inc.
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
Terminated
JFYK073055
Jan 24, 2020Siemens Healthcare Diagnostics, Inc.
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Terminated
JFYK070727
Jan 24, 2020Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
Terminated
JFYK070727
Aug 15, 2019Beckman Coulter Inc
Enzymatic Creatinine Reagent (CR-E 2 X 200), REF A60298, For in Vitro Diagnostic Use, Rx Only, UDI: 15099590625733
Terminated
JFYK091742
Jul 11, 2018Ortho-Clinical Diagnostics
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quant
Terminated
JFYK063591
Jun 27, 2017Sentinel CH SPA
MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems
Terminated
JFYK073634
Apr 3, 2017Beckman Coulter Inc.
Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine.
Terminated
JFYK093458
Mar 17, 2016Siemens Healthcare Diagnostics, Inc.
Dimension Vista Assays: Enzymatic Creatine (ECRE)
Terminated
JFYK090330
Mar 17, 2016Siemens Healthcare Diagnostics, Inc.
Dimension Assays: ENZYMATIC CREATININE
Terminated
JFYK073055
Mar 17, 2016Siemens Healthcare Diagnostics, Inc.
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
Terminated
JFYK070727
Sep 5, 2015Siemens Healthcare Diagnostics, Inc.
Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determi
Terminated
JFYK061238
K925668
Jun 27, 2015Roche Diagnostics Operations, Inc.
Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.
Terminated
JFYK003261
Apr 23, 2014Ortho-Clinical Diagnostics
VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721
Terminated
JFYK071216
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VIT
Terminated
JFYK063591
Jun 28, 2012Polymer Technology Systems, Inc.
PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidne
Terminated
JFYK010456
May 10, 2011Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension
Terminated
JFYK073055
May 9, 2011Siemens Healthcare Diagnostics, Inc.
Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in h
Terminated
JFYK090330
Sep 16, 2010Siemens Healthcare Diagnostics, Inc.
Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista Syst
Terminated
JFYK090330
Mar 16, 2010Abaxis Inc
Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc
Terminated
JFYK942782
Sep 30, 2009Diagnostic Chemicals, Ltd.
DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP.
Terminated
JFYK070383
Sep 30, 2009Diagnostic Chemicals, Ltd.
DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine.
Terminated
JFYK070383
Dec 13, 2008Dade Behring, Inc.
Dimension Enzymatic Creatinine Flex reagent cartridge, DF270. The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the
Terminated
JFYK073055
Oct 9, 2008Roche Diagnostics Corp.
Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 03263991190. An in-vitro diagnostic reagent system intended for use on COBAS Int
Terminated
JFYK024098

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