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

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA establishment

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

Newest first, rows 1-50 of 121

Search and filter all 121 devices

Rows 1-50 of 121

Showing 1-50 of 121

FDA establishments1

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

The Binding Site Kings Norton Birmingham · GB FEI 3012471076

Frequently asked questions

How many devices does The Binding Site, Ltd. have in the registry?

The registry currently lists 121 devices for The Binding Site, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list The Binding Site, Ltd.'s devices?

Among its 50 most recently registered devices, The Binding Site, Ltd. has devices listed in FDA 510(k) (50 devices).

What risk classes do The Binding Site, Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for The Binding Site, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from The Binding Site, Ltd. in the registry?

The most recently registered devices listed for The Binding Site, Ltd. include ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT, ANTI-TPO EIA DIAGNOSTIC TEST KIT, ENA SCREENING CIE KIT FOR DIAGNOSTIC USE and IGA MININEPH ANTISERUM.

Which FDA establishments are linked to The Binding Site, Ltd.?

1 FDA establishment is linked to The Binding Site, Ltd. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

At a glance

Market reach

What The Binding Site, Ltd. makes

Catalogue121

Alpha-1-Antitrypsin Immunological Nl Test Kit Ref K913666

Anti-Tpo Eia Diagnostic Test Kit Ref K984163

Ena Screening Cie Kit For Diagnostic Use Ref K924262

Iga Minineph Antiserum Ref K981786

Anticardiolipin Iga Screen Eia Diagnostic Test Kit Ref K983696

Human Protein S Rid Test Kit Ref K951640

Transferrin Rid Kit Ref K914390

Human (Igg) Subclass (Eia) Kit Ref K895600

Human Iga Liquid Reagent Kit For Use On Spaplus Ref K081827

Bindazyme Anti-Tissue Transglutaminase Iga Eia Ref K993612

Retinol Binding Rid Kit Ref K955881

Sheep Anti-Human Kappa Free Light Chain Immunofixation Grade Kit Ref K002564

Human Igd Immunological Nl Test Kit Ref K913671

Freelite Human Kappa And Lambda Free Kits For Use On The Bayer Advia 1650 Analyzer Ref K051915

Igg Subclass Single Dilution Diagnostic Kit For Use With The Beckman Array Analyzer Ref K940422

Minineph Human B2-Microglobulin Kit Ref K014270

Bindazyme Antigliadin Igg Ref K981644

Human Beta-2 Microglobin En-Rid Kit Ref K913131

Ige Eia Test Kit Ref K920087

Human Igg Subclass Liquid Reagent Kits, Product Code LK001.T Ref K012296

Farrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay Kit Ref K062183

En Typing Cie Kit For Diagnostic Use Ref K925118

Haptoglobin Immunological Test Kit Ref K913670

Cystatin C Kit For Use On The Spaplus Analyzer Ref K072166

Human Igm Liquid Reagent Kit For Use On The Spaplus Analyzer Ref K082129

Bindazyme Anti-PR3 Enzyme Immunoassay Kit Ref K981029

Binding Site Bindazyme Anti-Gbm Eia Diagnostic Test Kit Ref K984619

Ena Eia Kit Ref K010147

Freelite Human Kappa And Lambda Free Diagnostic Test Kits For Use On The Roche Cobas Integra 400/400 Plus Analyzer Kit Ref K070900

Hep-2 Ana Test System With If-Aim Technology Ref K001556

Albumin Test Rid Kit Ref K914391

Rid Plate Reader Ref K881174

C4 Minineph Antiserum Ref K981785

Bindazyme Anti-B2 GP1 Igg Eia Test Kit Ref K991801

Anticardiolipin Igg Screen Eia Diagnostic Test Ref K983692

Turbidimetric/Nephelometric Human Serum Reference Preparation Ref K981914

C3 Minineph Antiserum Ref K981783

Human Iga Liquid Reagent Kit For Use On SpA Plus Ref K103824

Sheep Anti-Human Ige Immunofixation Grade Kit Ref K002560

Human Igg Subclass Liquid Reagent Kits (For Use On Hitachi 911/ 912/ 917 And Modular P) Ref K090920

C1 Rid Kit Ref K914388

Caeruloplasmin Immunological Nl Test Kit Ref K913668

Human Igg Subclass Kit For Use On The Beckman Immage Analyser Ref K022083

Igm Minineph Antiserum Ref K981784

Ena Eia Kit Range Ref K010146

Immunoglobulin A Test System Ref K881827

Power Supply Ref K924021

Sheep Anti-Human Lambda Free Light Chain Immunofixation Grade Kit Ref K002563

Monoclonal Radial Immunodiffusion Kit Ref K881928

Bindazyme Anti-B2 Screen Eia Test Kit. Ref K991804

FDA establishments1

Frequently asked questions