Lorne Laboratories Ltd
GB-MF-000029354 · United Kingdom · Lower Earley
Lorne Laboratories Ltd is registered in the European database on medical devices as a manufacturer, with 5 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: ABO Monoclonal Antibody Reagent, Rhesus Monoclonal Antibody Reagents.
Authorised representative in the Union: Advena Limited.
Devices declared under this manufacturer
- Anti-A Monoclonal (1 X 10ml)
- Anti-A,B Monoclonal (1 X 10ml)
- Anti-B Monoclonal (1 X 10ml)
- Monoclonal D Negative Control (1 X 10ml)
- Papenzyme-Plus
Catalogue references include 441010, 600010, 610010, 620010, 650010.
European nomenclature codes declared: W0103030102, W0103030307, W0103030499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 5 |
| Country of registration | United Kingdom |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 4 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | LORNE LABORATORIES LTD. |
What it holds in Canada
| Licences on record | 3 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 3 |
| First licensed | 2011-08-29 |
Licence types: Device Family (3).
Licensed under: HUMAN BLOOD GROUPING REAGENTS, MONOCLONAL IGM BLOOD GROUPING REAGENTS, MONOCLONAL BLOOD GROUPING REAGENTS.
North American profile: Canada only. Lorne Laboratories Ltd holds a Canadian licence but was not found in the U.S. register.