FDA.reportPublic FDA data

Human IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit – Bulk Kit

Primary DI
05051700010375
Brand
Human IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit – Bulk Kit
Company
THE BINDING SITE GROUP LIMITED
Model
RK015
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
CZPIga, Antigen, Antiserum, Control

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931806000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931806000IGA SUBCLASS RID KIT FOR DIAGNOSTIC USEThe Binding Site, Ltd.1993-07-16CZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700010375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700010375050517000103755051700010375

GMDN Terms#

Term, Definition table
TermDefinition
Immunoglobulin A subclass (IgA subclass) IVD, kit, precipitation/immunodiffusionA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin A subclasses (IgA subclasses) in a clinical specimen, using a precipitation/immunodiffusion method.

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
05700572001140Poly Rb A-Hu IgAAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZP2022-01-27
00380740171711AlinityABBOTT IRELANDCZP2021-04-29
00380740171704ARCHITECTABBOTT IRELANDCZP2021-04-02
00380740175177ARCHITECTAbbott GmbHCZP2020-11-06
03610230007334Yumizen C1200 Immunoglobulin AHORIBA ABX SASCZP2020-07-13
00630414285030N Latex IgASiemens Healthcare Diagnostics Products GmbHCZP2020-06-23
07613336121313Tina-quant IgA Gen.2Roche Diagnostics GmbHCZP2020-03-05
00380740153915AlinityAbbott GmbHCZP2020-01-01
B1761020Antiserum to Human IgA (alpha chain specific)KENT LABORATORIES INCCZP2016-09-24
05055273203882IgARANDOX LABORATORIES LIMITEDCZP2016-09-24
05055273203899IgARANDOX LABORATORIES LIMITEDCZP2016-09-24
05055273203905IgARANDOX LABORATORIES LIMITEDCZP2016-09-24
00842768007200N Latex IgASiemens Healthcare Diagnostics Products GmbHCZP2016-09-24
04015630913411Immunoglobulin ARoche Diagnostics GmbHCZP2016-09-20
04015630919666Tinaquant IgA Gen2Roche Diagnostics GmbHCZP2016-09-20
04015630919680Tinaquant IgA Gen2Roche Diagnostics GmbHCZP2016-09-20
04015630925728Tinaquant IgA Gen2Roche Diagnostics GmbHCZP2016-09-20
05055273203820IgARANDOX LABORATORIES LIMITEDCZP2016-09-16
05700572000617Poly Rb A-Hu IgAAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZP2016-09-16
05700572000860Poly Rb A-Hu IgA, IgG, IgMAGILENT TECHNOLOGIES SINGAPORE PTE LTDCZP2016-09-16
00380740000493ARCHITECTABBOTT LABORATORIESCZP2016-09-09
00380740019754ARCHITECTABBOTT LABORATORIESCZP2016-06-06