The Binding Site, Ltd.

Also registered as THE BINDING SITE, INC., The Binding Site

Country not established FDA

Devices: 121
Registrations: FDA
FDA recalls: 0

What The Binding Site, Ltd. makes

The company produces immunological and immunological diagnostic test kits for detecting specific human proteins and antibodies, including alpha-1-antitrypsin, anti-thyroid peroxidase (anti-TPO), extractable nuclear antigens (ENA), IgA subclass antibodies, anticardiolipin IgA, protein S, transferrin, retinol-binding protein, and tissue transglutaminase IgA. It also supplies reagents for immunofixation and liquid-based immunoassay systems, such as IgG subclass and free light chain detection.

These products are classified under FDA’s Class I and Class II regulatory categories, with some devices authorised via the 510(k) pathway. The company’s devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue121

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FDA establishments1

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

The Binding Site Kings Norton Birmingham · GB FEI 3012471076

The Binding Site, Ltd.

What The Binding Site, Ltd. makes

Catalogue121

Bindazyme Anti-Dsdna Eia Kit Ref K993727

Immunoglobulin M Test System Ref K881828

Total Haemolytic Complement Rid Kit Ref K992488

Freelite Human Kappa And Lambda Free Kits For Use On The Spaplus Analyzer Ref K062372

Igd Diagnostic Test Kits Ref K051299

Minineph A-1 Antitrypsin Antiserum, High And Low Serum Controls Ref K011663

Minineph Human Rheumatoid Factor Kit Ref K041891

Bindazyme Human Anti-Phosphatidylserine Iga, Igg And Igm Enzyme Immunoassay Kit Ref K032240

Human Igg Subclass Liquid Reagent Kits For Use On The Hitachi 911/7070 Turbidimetric Analyser Ref K021081

Human Igd Kit For Use On Spaplus Ref K092450

Human Beta-2 Microglobulin Enhanced Radial Immunodiffusion Kit Ref K946068

Complement C1 Inactivator Kit Ref K915431

Anticardiolipin Igm Screen Eia Diagnostic Test Kit Ref K983694

Human Igg Subclass Liquid Reagent Kits, Product Code NK001.T Ref K012295

Ana Eia Diagnostic Test Kit Ref K004019

Human Beta-2 Microglobulin Kit Ref K083289

Alpha-2 Macroglobulin Test Rid Kit Ref K914389

Hevylite Human Iga Kappa Kit For Use On Siemens Bnii, Hevylite Human Iga Lambda Kit For Use On Siemens Bnii Ref K140105

Bindazyme Anti-Mpo Enzyme Immunoassay Kit Ref K981030

Prealbumin Immunological Nl Test Kit Ref K913672

Igg And Igg Subclass Nephelometric Diagnostic Test Kits Ref K982100

FDA establishments1