Alba Bioscience Limited
GB-MF-000029300 · United Kingdom · Penicuik
Alba Bioscience Limited is registered in the European database on medical devices as a manufacturer, with 60 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: 6904487 (FD153B), 6904491 (FD186B), 6904494 (FD171B), Z001, Z011.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- ALBAcheck® - BGS AB Serum (Human)
- ALBAcheck® - BGS Anti-D <0.1 IU/mL
- ALBAclone® Anti-A
- ALBAclone® Anti-B
- ALBAclone® Anti-E
- ALBAclone® Anti-human C3
- ALBAcyte® Reagent Red Cells for Antibody Identification (papainised)
- ALBAsera® Anti-Lub
- ALBAsera® Anti-Wra
- Anti-A1 LECTIN
- Monospecific Anti-Human IgG
- ORTHO™ Anti-s
Showing 12 of 60 declared devices.
Catalogue references include 6904487 (FD153B), 6904491 (FD186B), Z001, Z011, Z073, Z231.
European nomenclature codes declared: W0103030501, W0103030499, W0103030201, W0103030102, W0103030101, W0103030202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ALBA BIOSCIENCE LIMITED (GB) · FDA 3011683976 |
| Devices in EUDAMED | 60 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 59 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ALBA BIOSCIENCE LIMITED |
North American profile: Both markets. Alba Bioscience Limited is registered in both the United States and Canada.