The Binding Site Group Ltd
UK-MF-000036707 · United Kingdom · Birmingham
The Binding Site Group Ltd is registered in the European database on medical devices as a manufacturer, with 119 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: IK820, LK001.P, LK016.OPT, LK018.OPT, LK088.OPT.
Authorised representative in the Union: The Binding Site Ireland Limited.
Devices declared under this manufacturer
- EXENT® HCCA MALDI Matrix Pack
- Human Complement C5 NL BINDARID™ Kit
- Human IgG Subclass Combi Kit (for Siemens BN ProSpec®)
- Human IgG1 Subclass Bulk Kit (for Siemens BN™II)
- Human IgG1 Subclass Kit (for Siemens BN™II)
- Human IgG1 Subclass Kit - (for use on the Siemens BN ProSpec®)
- Human IgG2 Subclass Kit (for Siemens BN™II)
- Immunoglobulin Isotypes (GAM) for the EXENT® Analyser
- Optilite Freelite Kappa Free Kit
- Optilite® C4 Control Pack
- Optilite® Freelite® Kappa Free Kit (x10)
- Optilite® Freelite® Lambda Free Kit (x10)
Showing 12 of 119 declared devices.
Catalogue references include LK016.10.OPT, LK018.10.OPT, MSR801.M, NK006.TB, NK007.TB, NK626.OPT.
European nomenclature codes declared: W0102010106, W0102010109, W0102010107, W0102010105, W0102010101, W0102010102.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | The Binding Site Group Ltd. (GB) · FDA 9614373 |
| Devices in EUDAMED | 119 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 119 |
|---|---|
| Found in the U.S. device database | 55 |
| Share | 46.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | THE BINDING SITE GROUP LIMITED |
What it holds in Canada
| Licences on record | 6 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 5 |
| Class 3 devices | 1 |
| First licensed | 2001-11-06 |
Licence types: Test Kit (4), System (2).
Licensed under: OPTILITE ANALYSER, EXENT ANALYSER, FREELITE HUMAN KAPPA KITS, FREELITE HUMAN LAMBDA KIT, BINDAZYME ANTI PCP EIA KIT (PNEUMOCOCCAL CAPSU, BINDAZYME HUMAN ANTI HEMOPHILUS INFLUENZA EIA .
North American profile: Both markets. The Binding Site Group Ltd is registered in both the United States and Canada.