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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.

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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