FDA.reportPublic FDA data

Yumizen C1200 Ferritin

Primary DI
03610230007327
Brand
Yumizen C1200 Ferritin
Company
HORIBA ABX SAS
Model
1300023880
Published
2020-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DBFFerritin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBFFerritin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191562000Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorHORIBA ABX SAS2020-03-06DBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03610230007327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610230007327036102300073273610230007327

GMDN Terms#

Term, Definition table
TermDefinition
Ferritin IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of ferritin in a clinical specimen, using a nephelometry/turbidimetry 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
00630414293646Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2020-05-31
00630414294162Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2020-05-31
07613336121238Tina-quant Ferritin Gen.4Roche Diagnostics GmbHDBF2020-03-05
00380740156275ARCHITECTABBOTT LABORATORIESDBF2020-03-03
00380740156329ARCHITECTABBOTT LABORATORIESDBF2020-03-03
00850392007251BioCheck Human Ferritin EIA Test KitBIOCHECK, INC.DBF2019-10-08
04560189212251AIA-PACK FER Calibration Verification Test SetTOSOH CORPORATIONDBF2019-07-25
14560189212258AIA-PACK FER Calibration Verification Test SetTOSOH CORPORATIONDBF2019-07-25
08600000686017Spectro Ferritin MTRamco Laboratories, Inc.DBF2019-03-23
00840239018724Ferritin ELISADRG International IncDBF2019-03-20
00380740131470AlinityABBOTT IRELANDDBF2018-07-31
00380740131487AlinityABBOTT IRELANDDBF2018-07-31
00630414598925Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2018-02-06
00630414598932Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2018-02-06
B24225FERHUE010Ferritin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.DBF2017-08-03
14560189210483ST AIA-PACK FERTOSOH CORPORATIONDBF2016-09-24
15099590011901AUBeckman Coulter, Inc.DBF2016-09-24
B1761380Antiserum to Human FerritinKENT LABORATORIES INCDBF2016-09-24
04560189211452AIA-PACK FER Sample Diluting SolutionTOSOH CORPORATIONDBF2016-09-24
04560189211469ST AIA-PACK FER Calibrator SetTOSOH CORPORATIONDBF2016-09-24
05055273203073FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
05055273203080FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
05055273203097FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
00842768008085N Latex FerritinSiemens Healthcare Diagnostics Products GmbHDBF2016-09-24
00842768015182Dimension Vista® Flex® reagent cartridge FERRSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00857969006167ACEALFA WASSERMANN, INC.DBF2016-09-24
00630414177144ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414177151ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414204703ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414586069ADVIA® Chemistry FRT Ferritin ReagentsSiemens Healthcare Diagnostics Inc.DBF2016-09-24