FDA.reportPublic FDA data

Yumizen C1200 Magnesium

Primary DI
03610230007112
Brand
Yumizen C1200 Magnesium
Company
HORIBA ABX SAS
Model
1300023859
Published
2020-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JGJPhotometric Method, Magnesium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGJPhotometric Method, MagnesiumClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060205000GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx2006-07-21CJE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610230007112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610230007112036102300071123610230007112

GMDN Terms#

Term, Definition table
TermDefinition
Magnesium (Mg2+) IVD, kit, spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of magnesium (Mg2+) in a clinical specimen, using a 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
10673486002096Teco Diagnostics Magnesium Reagent SetTECO DIAGNOSTICSJGJ2023-11-14
10673486002126Teco Diagnostics Magnesium Reagent Kit for TC-Matrix TECO DIAGNOSTICSJGJ2023-11-14
00817302024104CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT AU-220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024203CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT BL220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024289CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT CC220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024449CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT DT220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00817302024586CAROLINA LIQUID CHEMISTRIES CORP.® MAGNESIUM REAGENT KIT ST220CAROLINA LIQUID CHEMISTRIES CORPORATIONJGJ2022-08-19
00380740169855ARCHITECTABBOTT IRELANDJGJ2022-05-24
00380740169862ARCHITECTABBOTT IRELANDJGJ2022-05-24
00380740176525AlinityABBOTT IRELANDJGJ2021-12-27
00380740176532AlinityABBOTT IRELANDJGJ2021-12-27
04015630913381MagnesiumRoche Diagnostics GmbHJGJ2021-02-08
04015630926992MagnesiumRoche Diagnostics GmbHJGJ2021-02-08
04015630930821Magnesium Gen.2Roche Diagnostics GmbHJGJ2021-02-08
00811727015938Pointe Magnesium ReagentHORIBA INSTRUMENTS INCORPORATEDJGJ2021-01-30
00811727016232Pointe Magnesium Reagent HORIBA INSTRUMENTS INCORPORATEDJGJ2021-01-30
00630414595597Atellica CH MgSiemens Healthcare Diagnostics Inc.JGJ2020-09-24
00842768014185Dimension® Flex® reagent cartridge MGSiemens Healthcare Diagnostics Inc.JGJ2020-09-24
00842768015694Dimension Vista® Flex® reagent cartridge MGSiemens Healthcare Diagnostics Inc.JGJ2020-09-24
10758750000265VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGJ2020-05-29
10758750004621VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JGJ2020-05-29
07613336121412Magnesium Gen.2Roche Diagnostics GmbHJGJ2020-03-05
07613336169438Magnesium Gen.2Roche Diagnostics GmbHJGJ2019-07-01
05055273204629MAGNESIUM (Mg)RANDOX LABORATORIES LIMITEDJGJ2019-06-03
05055273209303MAGNESIUM (Mg)RANDOX LABORATORIES LIMITEDJGJ2019-06-03
00386100002169Mg Reagent KitMEDICA CORPORATIONJGJ2019-02-14
00380740121839AlinityAbbott GmbHJGJ2019-02-12
00380740121846AlinityAbbott GmbHJGJ2019-02-12
00380740161620ARCHITECTAbbott GmbHJGJ2019-02-05
00380740161637ARCHITECTAbbott GmbHJGJ2019-02-05