FDA.reportPublic FDA data

Optilite Haptoglobin Kit

Primary DI
05051700017626
Brand
Optilite Haptoglobin Kit
Company
THE BINDING SITE GROUP LIMITED
Model
NK058.OPT.A
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
DADHaptoglobin, Antigen, Antiserum, Control

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700017626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700017626050517000176265051700017626

GMDN Terms#

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414610986Atellica CH HAPT2Siemens Healthcare Diagnostics Inc.DAD2023-08-28
00630414305080Atellica CH HAPT2Siemens Healthcare Diagnostics Inc.DAD2023-08-28
00380740169879AlinityABBOTT IRELANDDAD2021-05-13
00380740169886ARCHITECTABBOTT IRELANDDAD2021-03-19
07613336140772Tina-quant Haptoglobin ver.2Roche Diagnostics GmbHDAD2020-03-05
00380740150686AlinityAbbott GmbHDAD2019-07-08
05055273203806HAPTOGLOBIN (HP)RANDOX LABORATORIES LIMITEDDAD2019-06-03
06970291985161Haptoglobin Kit (Immunoturbidimetric Method)Medicalsystem Biotechnology Co., Ltd.DAD2019-03-07
00630414210827Atellica™ CH HaptSiemens Healthcare Diagnostics Inc.DAD2018-12-08
15099590010621AUBeckman Coulter, Inc.DAD2016-09-24
B1761120Antiserum to Human HaptoglobinKENT LABORATORIES INCDAD2016-09-24
05051700016094Human Haptoglobin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDAD2016-09-24
00842768006111DImension Vista® Haptoglobin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDAD2016-09-24
00630414491356ADVIA® Chemistry HAPT Haptoglobin ReagentsSiemens Healthcare Diagnostics Inc.DAD2016-09-24
00630414506005ADVIA® Chemistry HAPT Haptoglobin ReagentsSiemens Healthcare Diagnostics Inc.DAD2016-09-24
04015630906765Tinaquant HaptoglobinRoche Diagnostics GmbHDAD2016-09-20
04015630916580Tinaquant Haptoglobin ver2Roche Diagnostics GmbHDAD2016-09-20
04015630928620Tinaquant Haptoglobin ver2Roche Diagnostics GmbHDAD2016-09-20
00816426020153K-ASSAY® Haptoglobin ReagentKAMIYA BIOMEDICAL COMPANY, LLCDAD2016-09-16
10758750002283VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DAD2016-08-26
15099590224431SynchronBeckman Coulter, Inc.DAD2016-08-24
15099590230456IMMAGEBeckman Coulter, Inc.DAD2016-08-24
00380740019693ARCHITECTABBOTT LABORATORIESDAD2016-06-06