FDA.reportPublic FDA data

Human Antithrombin III BINDARID™ Radial Immunodiffusion Kit

Primary DI
05051700010702
Brand
Human Antithrombin III BINDARID™ Radial Immunodiffusion Kit
Company
THE BINDING SITE GROUP LIMITED
Model
RN040.3
Published
2016-09-24
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
JBQAntithrombin Iii Quantitation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBQAntithrombin Iii QuantitationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913667000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913667000ANTITHROMBIN III IMMUNOLOGICAL NL TEST KITThe Binding Site, Ltd.1992-01-03JBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700010702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700010702050517000107025051700010702

GMDN Terms#

Term, Definition table
TermDefinition
Antithrombin III (ATIII) IVD, kit, precipitation/immunodiffusionA collection of reagents and other associated materials intended to be used for the quantitative measurement of antithrombin III (ATIII) in a clinical specimen, using a precipitation/immunodiffusion method. ATIII inhibits coagulation and its deficiency is a result of a rare hereditary disorder, which increases the risk of thrombosis.

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
+441214569500info@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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414639673INNOVANCE AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2024-03-25
00630414639680INNOVANCE AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2024-03-25
00630414639796INNOVANCE AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2024-03-25
00195226000061HemosIL Liquid AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2021-01-29
00842768037146INNOVANCE AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2020-05-07
B1761480Antiserum to Human Antithrombin IIIKENT LABORATORIES INCJBQ2016-09-24
B1761484Antithrombin III RID plate packageKENT LABORATORIES INCJBQ2016-09-24
B1761485Antithrombin III RID plate packageKENT LABORATORIES INCJBQ2016-09-24
00842768013065Enzygnost® TAT microSiemens Healthcare Diagnostics Products GmbHJBQ2016-09-24
00842768027017INNOVANCE® AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2016-09-24
00842768027024INNOVANCE® AntithrombinSiemens Healthcare Diagnostics Products GmbHJBQ2016-09-24
08426950358701HemosIL Liquid AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950056003HemosIL Liquid AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950087571HemosIL Liquid AT SubstrateINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950440802HemosIL Liquid AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950062325HemosIL AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950088936Coamatic LR AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
08426950088868Coamatic AntithrombinINSTRUMENTATION LABORATORY COMPANYJBQ2016-09-23
00850201006086ACTICHROME ATIII KITBiomedica ADI Inc.JBQ2016-09-20
03607450005684Liatest® AT IIIDIAGNOSTICA STAGOJBQ2016-09-15
03607450005967STA® - Stachrom® AT III 3DIAGNOSTICA STAGOJBQ2016-09-15
05391521420534TriniCHROM™ Antithrombin IIaTCOAG IRELAND LIMITEDJBQ2016-09-12
05391521420541TriniCHROM™ Antithrombin XaTCOAG IRELAND LIMITEDJBQ2016-09-12
03663537008207BIOPHEN Antithrombin 2.5HYPHEN BIOMEDJBQ2016-08-25
03663537008214BIOPHEN Antithrombin 5HYPHEN BIOMEDJBQ2016-08-25