JFY

Product Code: JFY


Products Classified as JFY

390Enzymatic Method, CreatinineCreatinine Test System.

Total Product Life Cycle (TPLC) Devices

390Enzymatic Method, CreatinineCreatinine Test System.

FDA Consensus Standards

Enzymatic Method, Creatinine [32368]21 CFR §862.1225 🔎

Pre-market Notifications for JFY

K212223Atellica CH Enzymatic Creatinine_3 (ECre3)Siemens Healthcare Diagnostics Inc.
K193649Yumizen C1200 Creatinine PAPHoriba ABX SAS
K183555GEM Premier ChemSTATInstrumentation Laboratory Co.
K182384ACR LAB Urine Analysis Test SystemHealthy.io Ltd
K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc.
K182038URiSCAN 10ACR Urine Strips On The URiSCAN Optima Urine AnalyzerYD Diagnostics Corporation
K161527Teco Creatinine Enzymatic Reagent KitTECO DIAGNOSTICS, INC.
K152835URITEK TC-201 URINE CHEMISTRY TEST SYSTEMTECO DIAGNOSTICS, INC.
K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )ACON LABORATORIES, INC.
K132399ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVELELITECH GROUP
K110137ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URINHORIBA ABX S.A.S.
K103376ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CLSEPPIM S.A.S.
K093458SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298BECKMAN COULTER, INC.
K091742SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298BECKMAN COULTER, INC.
K090330DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270Siemens Healthcare Diagnostics Inc.

Global Unique Device Identification Database

00381931720015ENZYMATIC METHOD, CREATININE
00380740136178ENZYMATIC METHOD, CREATININE
00380740136161ENZYMATIC METHOD, CREATININE
00380740017699ENZYMATIC METHOD, CREATININE
00380740017682ENZYMATIC METHOD, CREATININE
00630414595795ENZYMATIC METHOD, CREATININE
00630414574639ENZYMATIC METHOD, CREATININE
00630414551111ENZYMATIC METHOD, CREATININE
00630414548951ENZYMATIC METHOD, CREATININE
00630414526690ENZYMATIC METHOD, CREATININE
00628063400423ENZYMATIC METHOD, CREATININE
00628063400393ENZYMATIC METHOD, CREATININE
00657498001554Enzymatic Method, Creatinine
00657498000762Enzymatic Method, Creatinine
00657498000755Enzymatic Method, Creatinine

Maude Adverse Events

VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-03-16
ECRE_2 REAGENTS (4 X 350 TESTS) - ENZSIEMENS HEALTHCARE DIAGNOSTICS INC.2020-03-06
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-21
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2020-02-18
CREATININE PLUS VER.2ROCHE DIAGNOSTICS2019-11-27
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-10-15
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-10-15
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-10-15
CREATININE PLUS VER.2ROCHE DIAGNOSTICS2019-10-03
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-26
CREATININE PLUS VER.2ROCHE DIAGNOSTICS2019-09-17
CREP2 CREATININE PLUS VER.2ROCHE DIAGNOSTICS2019-09-13
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-04
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-04
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-04
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-04
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-04
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-04
VITROS CHEMISTRY PRODUCTS CREA SLIDESORTHO-CLINICAL DIAGNOSTICS2019-09-04
CREATININE PLUS VER.2ROCHE DIAGNOSTICS2019-08-30
CREATININE PLUS VER.2ROCHE DIAGNOSTICS2019-07-26
CREATININE PLUS VER.2ROCHE DIAGNOSTICS2019-07-26
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.