FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740171285
Brand
ARCHITECT
Company
ABBOTT IRELAND
Model
01E0424
Catalog number
01E0424
Device description
TRANSFERRIN 390 Tests
Published
2021-03-26
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
DDGTRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740171285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740171285003807401712853807401712850380740171285

GMDN Terms#

Term, Definition table
TermDefinition
Transferrin IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of transferrin in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius
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
00894175000473AccuDiag™Diagnostic Automation, Inc.DDG2021-09-07
00380740171278AlinityABBOTT IRELANDDDG2021-03-26
00380740179021ARCHITECTABBOTT IRELANDDDG2021-03-26
04015630919444sTfR Control SetRoche Diagnostics GmbHDDG2021-02-08
00380740161439ARCHITECTAbbott GmbHDDG2020-11-06
00380740161446ARCHITECTAbbott GmbHDDG2020-11-06
07613336147924Tina-quant Soluble Transferrin ReceptorRoche Diagnostics GmbHDDG2020-10-29
03610230007419Yumizen C1200 TransferrinHORIBA ABX SASDDG2020-05-06
07613336121573Tina-quant Transferrin ver. 2Roche Diagnostics GmbHDDG2020-03-05
00380740135096AlinityAbbott GmbHDDG2019-06-27
00816870020341sTfR AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DDG2019-02-11
00816870020358sTfR AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DDG2019-02-11
00816870022024sTfR AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DDG2019-02-11
00816870022031sTfR AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DDG2019-02-11
B1761250Antiserum to Human TransferrinKENT LABORATORIES INCDDG2016-09-24
05051700010788Human Transferrin BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDDDG2016-09-24
05051700017640Optilite Transferrin KitTHE BINDING SITE GROUP LIMITEDDDG2016-09-24
05055273206494TFRANDOX LABORATORIES LIMITEDDDG2016-09-24
05055273206500TFRANDOX LABORATORIES LIMITEDDDG2016-09-24
00842768005244Dimension® Flex® reagent cartridge TRNFSiemens Healthcare Diagnostics Inc.DDG2016-09-24
00842768006258DImension Vista® Transferrin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
00842768008054N Latex sTfRSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
00842768008061N Supplementary Reagent LSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
00842768009891N Antiserum to Human TransferrinSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
00842768009907N Antiserum to Human TransferrinSiemens Healthcare Diagnostics Products GmbHDDG2016-09-24
04015630914395Tinaquant Soluble Transferrin ReceptorRoche Diagnostics GmbHDDG2016-09-20
04015630917419Tinaquant Transferrin ver2Roche Diagnostics GmbHDDG2016-09-20
04015630917426Transferrin ver 2 Tinaquant Transferrin ver2Roche Diagnostics GmbHDDG2016-09-20
04015630917440Transferrin ver 2 Tinaquant Transferrin ver2Roche Diagnostics GmbHDDG2016-09-20
04015630918614Tinaquant Soluble Transferrin ReceptorRoche Diagnostics GmbHDDG2016-09-20