FDA.reportPublic FDA data

CH50 Eq Enzyme Immunoassay Kit

Primary DI
05051700012294
Brand
CH50 Eq Enzyme Immunoassay Kit
Company
THE BINDING SITE GROUP LIMITED
Model
MK095
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
DAEComplement C9, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAEComplement C9, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974111000QUIDEL CH50 EQ EIAQuidel Corp.1998-07-29DAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700012294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700012294050517000122945051700012294

GMDN Terms#

Term, Definition table
TermDefinition
Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the quantitative measurement of total complement activity (CH50) in a clinical specimen, using an enzyme immunoassay (EIA) 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
05051700021098Optilite® CH50 ReagentTHE BINDING SITE GROUP LIMITEDDAE2024-11-20
04987481164406Autokit CH50FUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2020-10-23
00498748116440Autokit CH50FUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2020-10-23
04987481164512CH50 CalibratorFUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2020-10-23
00856626006151CH50 CalibratorFUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2016-12-07
00856626006113Autokit CH50FUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2016-11-11
05051700010269Total Haemolytic Complement THE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700010276Total Haemolytic Complement THE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700010283Total Haemolytic Complement THE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700015592Human CH50 Reagent pack for use on the SPAPLUSTHE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700018210Optilite CH50 ReagentTHE BINDING SITE GROUP LIMITEDDAE2016-09-24
30014613335566MicroVueQUIDEL CORPORATIONDAE2016-09-15