FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740014070
Brand
ARCHITECT
Company
ABBOTT IRELAND
Model
7K59-01
Catalog number
07K5901
Device description
ARCHITECT Ferritin Calibrators
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DBFFERRITIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740014070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740014070003807400140703807400140700380740014070

GMDN Terms#

Term, Definition table
TermDefinition
Plasma protein IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of plasma proteins in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
989964119
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15

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
03610230007327Yumizen C1200 FerritinHORIBA ABX SASDBF2020-05-06
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