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The Binding Site Group Ltd

United Kingdom (ex Northern Ireland)·UK-MF-000036707

Last updated September 18, 2026

What The Binding Site Group Ltd makes

The company produces in-vitro diagnostic (IVD) reagents and kits for measuring specific human proteins and immune markers, including C-reactive protein, C1 inactivator, immunoglobulin subtypes (IgA, IgM, IgG), and free light chains. These products are designed for use on automated immunoassay platforms such as the SPAPlus, with some also available as standalone reagent sets. Additional offerings include controls, calibrators, and specialized assays for clinical applications like monitoring autoimmune diseases, immune dysfunction, and protein abnormalities.

The portfolio includes devices classified as Class B and Class C under EU regulations and Class II under the US system, reflecting varying levels of risk and regulatory oversight. These products are registered in the EU’s eudamed database and have undergone 510(k) clearance via the FDA’s premarket notification process. The manufacturer operates from the United Kingdom, adhering to both regional and international regulatory standards for IVD medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
United Kingdom (ex Northern Ireland)
Address
8, Calthorpe road, Birmingham, United Kingdom (ex Northern Ireland)
Website
www.bindingsite.com

This address returned "not found" when we last checked — the site may have moved. Last checked 2026-09-18.

LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+441214569500
PRRC Contact
Sheena Mistry
EUDAMED SRN
UK-MF-000036707
FDA FEI Number
—
DUNS Number
—

Catalogue (38)

DeviceModel / ReferenceRegistriesClassStatus
Human C1 Inactivator Kit For Use On Spaplus K122304
FDA 510(k)
Class IIActive
Optilite C-Reactive Protein Reagent, Optilite C-Reactive Protein Calibrator, Optilite C-Reactive Protein Controls K172868
FDA 510(k)
Class IIActive
Optilite High Sensitivity C-Reactive Protein Kit K180099
FDA 510(k)
Class IIActive
Human Iga2 Kit For Use On The Spaplus K100588
FDA 510(k)
Class IIActive
Human Iga Csf Kit For Use On Spaplus K120901
FDA 510(k)
Class IIActive
Optilite C1 Inactivator Kit K141100
FDA 510(k)
Class IIActive
Hevylite Human Igm Kappa And Hevylite Igm Lambda Kit K113823
FDA 510(k)
Class IIActive
Hevylite Human Iga Kappa And Iga Lambda Bn Kits K082823
FDA 510(k)
Class IIActive
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator K150412
FDA 510(k)
Class IIActive
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit K173732
FDA 510(k)
Class IIActive
Human IgM Kit for use on SPAPlus K191465
FDA 510(k)
Class IIActive
Transferrin Kit For Use On The Spaplus K120236
FDA 510(k)
Class IIActive
Human Microalbumin kit for use on SPAPLUS K143118
FDA 510(k)
Class IIActive
Human Kappa And Lambda Free Kitfor Use On The Spa Plus Analyser K120056
FDA 510(k)
Class IIActive
Human Caeruloplasmin Kit K122965
FDA 510(k)
Class IIActive
Rheumatoid Factor (RF) Kit for use on SPAPLUS K160070
FDA 510(k)
Class IIActive
Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS K151759
FDA 510(k)
Class IIActive
Human IgA liquid reagent kit for Use on SPAPlus K192116
FDA 510(k)
Class IIActive
Optilite IgM CSF Kit K190686
EUDAMEDFDA 510(k)
Class IIActive
Human Igg Csf Kit K120749
FDA 510(k)
Class IIActive
Optilite Rheumatoid Factor Kit K162263
FDA 510(k)
Class IIActive
Hevylite Human Igm Kappa And Lambda Kit For Use On Spaplus K140686
FDA 510(k)
Class IIActive
Human Albumin Csf Kit K121045
FDA 510(k)
Class IIActive
Human Ch50 Reagent Pack For Use On The Spaplus, Human Ch50 Calibrator Set For Use On The Spaplus, Human Ch50 Controls Fo K113349
FDA 510(k)
Class IIActive
Human Alpha-1 Antitrypsin Kit Spaplus K123256
FDA 510(k)
Class IIActive
Optilite Low Level Albumin Kit K153560
FDA 510(k)
Class IIActive
Optilite IgA CSF Kit K183151
FDA 510(k)
Class IIActive
Human Igm Csf Kit K120750
FDA 510(k)
Class IIActive
Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit K250549
FDA 510(k)
Class IIActive
Human Alpha2-Macroglobulin Kit For Use On Spaplus K140664
FDA 510(k)
Class IIActive
Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS K161854
FDA 510(k)
Class IIActive
Human Beta-2 Microglobulin Urine Kit For Use On The Spaplus K122066
FDA 510(k)
Class IIActive
Optilite® IgG1 Kit NK006.OPT
EUDAMED
Class BActive
Freelite® Human Lambda Free Control Pack For use on the Roche Cobas™ c Systems NQ018.CB
EUDAMEDFDA UDI
Class CActive
Optilite® IgG2 Kit NK007.OPT
EUDAMED
Class BActive
Optilite® IgM Kit NK012.OPT
EUDAMED
Class BActive
Optilite® Hevylite® IgM Kappa Kit NK625.OPT
EUDAMED
Class CActive
Optilite Freelite Kappa Free Kit LK016.OPT
EUDAMED
Class CActive

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FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

  • The Binding Site Group Ltd. BIRMINGHAM · GB FEI 3002808340
  • The Binding Site Group US