FDA.reportPublic FDA data

Yumizen C1200 Glucose HK

Primary DI
03610230007013
Brand
Yumizen C1200 Glucose HK
Company
HORIBA ABX SAS
Model
1300023848
Device description
R1= 6x39mLR2= 6x13mL
Published
2020-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CFRHexokinase, Glucose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFRHexokinase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183375000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183375000Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.2019-02-12JJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610230007013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610230007013036102300070133610230007013

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
273647420
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610230004883ABX PENTRA IMMUNO II CONTROL L/H12200016222016-08-23
03610230004623ABX CLEANER (0.5L)12109030112016-08-16
03610230009932ABX Micros 6013001465762026-01-23
03610230009444Yumizen H250013001021472024-11-29
03610230009451Yumizen H250013001021482024-11-29
03610230005774ABX PENTRA MICRO-ALB CAL12200019662016-09-05
03610230005781ABX PENTRA MICRO ALB CONTROL L/H12200019672016-08-16
03610230008232ABX Pentra Micro ALB 2 Cal13000325652017-07-07
03610230005187ABX PENTRA ALBUMIN CP12200016642016-08-23
03610230005767ABX PENTRA MICRO ALBUMIN CP12200019652016-08-16
03610230008225ABX Pentra Micro ALBUMIN 2 CP13000325632017-06-27
03610230007235Yumizen C1200 Albumin U/CSF13000238712020-09-14
03610230007464Yumizen C1200 Micro Alb U/CSF Cal Normal 1300023894 2020-09-07
03610230007891Yumizen C1200 U/CSF L1 Micro Alb Control 1300023948 2020-09-07
03610230007914Yumizen C1200 U/CSF L2 Micro Alb Control 1300023949 2020-09-07
03610230006825Yumizen C1200 Albumin13000237992020-05-06
03610230008966Yumizen P800013000333272025-07-07
03610230009611ABX Minocal530010030053001003002024-09-27
03610230008584BFTROL13000394052024-09-26
03610230009581ABX Minotrol 16530010031253001003122024-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654126Atellica CH GluH_3Siemens Healthcare Diagnostics Inc.CFR2026-03-18
00380740215712AlinityABBOTT LABORATORIESCFR2025-10-08
00850053916113IDG/SanzayIDG/SANZAY CorporationCFR2024-06-25
10673486001693Teco Diagnostics Glucose (Hexokinase) Reagent SetTECO DIAGNOSTICSCFR2023-11-10
10673486001709Teco Diagnostics Glucose (Hexokinase) Reagent SetTECO DIAGNOSTICSCFR2023-11-10
10673486001662Teco Diagnostics Glucose (Hexokinase) Liquid ReagentTECO DIAGNOSTICSCFR2023-11-09
10673486001686Teco Diagnostics Glucose Hexokinase (Liquid) Reagent Kit for TC-MatrixTECO DIAGNOSTICSCFR2023-11-09
07613336161791Glucose HK Gen. 3 Roche Diagnostics GmbHCFR2022-11-18
00811727016157Pointe Glucose ReagentHORIBA INSTRUMENTS INCORPORATEDCFR2021-01-30
00811727015846Pointe Glucose Hexokinase for BS480HORIBA INSTRUMENTS INCORPORATEDCFR2020-05-28
03610230007020Yumizen C1200 Glucose HKHORIBA ABX SASCFR2020-05-06
07613336121283Glucose HKRoche Diagnostics GmbHCFR2020-03-05
00380740161583ARCHITECTAbbott GmbHCFR2020-01-04
00380740161590ARCHITECTAbbott GmbHCFR2020-01-04
00817238011148Glucose UV REAGENTCLINIQA CORPORATIONCFR2018-08-23
00380740135447AlinityAbbott GmbHCFR2018-07-11
00380740135454AlinityAbbott GmbHCFR2018-07-11
00852169008140ClearChem Diagnostics Inc. GlucoseCLEARCHEM DIAGNOSTICS INC.CFR2018-04-30
00630414596488Atellica CH GluH_3Siemens Healthcare Diagnostics Inc.CFR2017-12-22
00817302023152CLC720 Chemistry Analyzer w/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONCFR2016-12-19
00817302023169CLC480 Chemistry Analyzer W/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONCFR2016-12-19
00817302022995CAROLINA LIQUID CHEMISTRIES CORP.® GLU REAGENT PRODUCT NO. DT208CAROLINA LIQUID CHEMISTRIES CORPORATIONCFR2016-10-17
00812137011985Glucose ReagentCLINICAL DIAGNOSTIC SOLUTIONS, INC.CFR2016-10-12
15099590010195AUBeckman Coulter, Inc.CFR2016-09-24
15099590020101AUBeckman Coulter, Inc.CFR2016-09-24
15099590060084AUBeckman Coulter, Inc.CFR2016-09-24
00842768005541Dimension® Flex® reagent cartridge GLUCSiemens Healthcare Diagnostics Inc.CFR2016-09-24
00842768015663Dimension Vista® Flex® reagent cartridge GLUSiemens Healthcare Diagnostics Inc.CFR2016-09-24
00857969006129ACEALFA WASSERMANN, INC.CFR2016-09-24
00630414526812ADVIA® Chemistry GLUH_3 Glucose Hexokinase_3 ReagentsSiemens Healthcare Diagnostics Inc.CFR2016-09-24