FDA.reportPublic FDA data

Human Transferrin BINDARID™ Radial Immunodiffusion Kit

Primary DI
05051700010788
Brand
Human Transferrin BINDARID™ Radial Immunodiffusion Kit
Company
THE BINDING SITE GROUP LIMITED
Model
RN070.3
Published
2016-09-24
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914390000TRANSFERRIN RID KITThe Binding Site, Ltd.1991-12-09DDG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700010788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700010788050517000107885051700010788

GMDN Terms#

Term, Definition table
TermDefinition
Transferrin IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of transferrin in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401214569500info@bindingsite.co.uk

Regulatory Flags#

DUNS number
347045614
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
05051700021104Freelite® Human Kappa Free Kit for use on the Roche cobas® c SystemsLK016.CB.A2026-02-02
05051700021111Freelite® Human Lambda Free Kit for use on the Roche cobas® c SystemsLK018.CB.A2026-02-02
05051700006316Freelite® Human Kappa Free Kit for use on the HITACHI 911/912/917/Modular P LK016.H2016-09-24
05051700006323Freelite® Human Kappa Free Kit for use on the Beckman Coulter IMMAGE®/IMMAGE®800LK016.IM2016-09-24
05051700006439Freelite® Human Lambda Free Kit for use on the Hitachi 911/912/917/Modular P LK018.H2016-09-24
05051700010269Total Haemolytic Complement RC001.12016-09-24
05051700010276Total Haemolytic Complement RC001.22016-09-24
05051700010283Total Haemolytic Complement RC001.32016-09-24
05051700010399Human IgG Subclass Single Dilution BINDARID™ Kit - Bulk KitRK0212016-09-24
05051700010504Human C1 Inactivator BINDARID™ Radial Immunodiffusion KitRN019.32016-09-24
05051700010559Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion KitRN025.32016-09-24
05051700010764Human Plasminogen ’NL’ BINDARID™ Radial Immunodiffusion KitRN065.32016-09-24
05051700010917Human IgG1 Subclass Single Dilution BINDARID™ KitsRN106.32016-09-24
05051700010924Human IgG2 Subclass Single Dilution BINDARID™ KitsRN107.32016-09-24
05051700010931Human IgG3 Subclass Single Dilution BINDARID™ KitsRN108.32016-09-24
05051700010948Human IgG3 Subclass Single Dilution BINDARID™ KitsRN109.32016-09-24
05051700016919Hevylite® Human IgA Kappa Kit for use on the Siemens BN™II NK623.T.A2016-09-24
05051700016926Hevylite IgA Lambda Kit for Siemens BNIINK624.T.A2016-09-24
05051700018715 Freelite® Human Lambda Free Control Pack For use on the Beckman Coulter IMMAGE™NQ018.IM2017-06-05
05051700018739 Freelite® Human Kappa Free Control Pack For use on the Beckman Coulter IMMAGE™/NQ016.IM2017-06-05

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Primary DI, Brand, Company table
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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
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00816870022024sTfR AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DDG2019-02-11
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B1761250Antiserum to Human TransferrinKENT LABORATORIES INCDDG2016-09-24
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
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