FDA.reportPublic FDA data

Optilite® IgG Kit (x10)

Primary DI
05051700020916
Brand
Optilite® IgG Kit (x10)
Company
THE BINDING SITE GROUP LIMITED
Model
NK004.10.OPT.A
Published
2022-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFNMethod, Nephelometric, Immunoglobulins (G, A, M)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072889000HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSERThe Binding Site, Ltd.2008-02-01CFN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051700020916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051700020916050517000209165051700020916

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin G (IgG total) 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
05051700020602EXENT® Immunoglobulin Isotypes (GAM) Control PackMSQ801.M2025-11-27
05051700020640EXENT® Diluent 1IK8762025-11-27
05051700020657EXENT® Elution buffer 1 IK8772025-11-27
05051700020664EXENT® HCCA MALDI Matrix PackIK8202025-11-27
05051700020671EXENT® Mass calibration standard 1 MSS801.M2025-11-27
05051700020688EXENT® Disposable MALDI plate pack IK8192025-11-27
05051700020695EXENT® Wash solution 1 IK8222025-11-27
05051700020886EXENT® AnalyserIE800.A2025-11-27
05051700021050Immunoglobulin Isotypes (GAM) for the EXENT AnalyserMSR801.M.A2025-11-27
05051700021098Optilite® CH50 ReagentNK095.OPT.A2024-11-20
05051700019392Optilite® Low Level Total Protein ControlsNQ061.L.OPT2024-10-30
05051700020534Optilite® Low Level Total Protein CalibratorNC061.L.OPT2024-10-30
05051700020558Optilite® Low Level Total Protein ReagentNK061.L.OPT.A2024-10-30
05051700021036Optilite® IgG3 Kit (x10)LK008.10.OPT.A2023-09-27
05051700021043Optilite® IgG4 Kit (x10)LK009.10.OPT.A2023-09-27
05051700016803Freelite® Kappa AMR Check Fluid SDBP538.SD2023-08-09
05051700016810Freelite® Lambda AMR Check Fluid SDBP539.SD2023-08-09
05051700002059Freelite® Panel Sample SetBP2282023-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051700021036Optilite® IgG3 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2023-09-27
05051700021043Optilite® IgG4 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2023-09-27
05051700020923Optilite® IgG1 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2022-11-21
05051700020930Optilite® IgG2 Kit (x10)THE BINDING SITE GROUP LIMITEDCFN2022-11-21
00630414285023N Latex IgMSiemens Healthcare Diagnostics Products GmbHCFN2020-05-29
05051700020183Optilite IgM CSF KitTHE BINDING SITE GROUP LIMITEDCFN2020-01-31
05051700020190Optilite IgA CSF KitTHE BINDING SITE GROUP LIMITEDCFN2019-06-21
00630414596266Atellica CH IgG_2Siemens Healthcare Diagnostics Inc.CFN2017-12-27
00630414595627Atellica CH IgM_2Siemens Healthcare Diagnostics Inc.CFN2017-12-21
00630414595610Atellica CH IgA_2Siemens Healthcare Diagnostics Inc.CFN2017-12-19
05051700019835Optilite IgG CSF KitTHE BINDING SITE GROUP LIMITEDCFN2017-05-26
15099590011574AUBeckman Coulter, Inc.CFN2016-09-24
15099590011581AUBeckman Coulter, Inc.CFN2016-09-24
15099590011598AUBeckman Coulter, Inc.CFN2016-09-24
05051700006033Human IgG Subclass Liquid Reagent Kit for use on tTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006088Human IgG Subclass Liquid Reagent Kit for use on tTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006095Human IgA Subclass Liquid Latex Reagent Kit for usTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006101Human IgG3 Subclass Liquid Reagent Kit for use on THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006118Olympus IgG3 KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006132Human IgG3 Subclass Liquid Reagent Kit for use on THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006149Beckman Immage IgG3 Latex KitTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006163Human IgG3 Subclass Liquid Reagent Kit for use on THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006170Human IgG4 Subclass Liquid Reagent Kit for use on THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006187Human IgG4 Subclass Liquid Reagent Kit for use on THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006224Human IgG4 Subclass Liquid Reagent Kit for use on THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006248Human IgG4 Subclass Liquid Reagent Kit for use on THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700006538Human IgA2 Subclass Liquid Latex Reagent Kit for uTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700007535Human IgG Subclass Liquid Reagent Kit for use on tTHE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700007559Human IgG2 Subclass Liquid Reagent Kit for use on THE BINDING SITE GROUP LIMITEDCFN2016-09-24
05051700007566Human IgG1 Subclass Liquid Reagent Kit for use on THE BINDING SITE GROUP LIMITEDCFN2016-09-24