Oxford Immunotec Ltd
GB-MF-000004429 · United Kingdom · Abingdon
Oxford Immunotec Ltd is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: AV.200/50 (A18398SA), AV.200/500 (A18398DJ), CMV.400, COV.435/300, LTK.615.
Among these devices, 2 are declared sterile.
Authorised representative in the Union: Wallac Oy.
Devices declared under this manufacturer
- AIM-V Medium
- T-Cell Select
- T-SPOT.CMV
- T-SPOT.COVID
- T-SPOT.TB
Catalogue references include AV.200/50 (A18398SA), AV.200/500 (A18398DJ), CMV.400, COV.435/300, LTK.615, TB.300.
European nomenclature codes declared: W0580, W0105900299, W01029099, W0103080199, W050301020101, W0105010704.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | OXFORD IMMUNOTEC LTD (GB) · FDA 3015492990 |
| Devices in EUDAMED | 8 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 8 |
|---|---|
| Found in the U.S. device database | 2 |
| Share | 25.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OXFORD IMMUNOTEC LTD. |
What it holds in Canada
| Licences on record | 1 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 1 |
| First licensed | 2005-10-27 |
Licence types: Test Kit (1).
Licensed under: T-SPOT.TB.
North American profile: Both markets. Oxford Immunotec Ltd is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IQMS/00008/0v001 | issued | 2031-04-13 |