Data / Medical devices / United Kingdom / Oxford Immunotec Ltd
Oxford Immunotec Ltd: FDA-registered device maker in Abingdon Oxfordshire, United Kingdom, 1 PMA approval
Oxford Immunotec Ltd is registered with the FDA (registration 3015492990) in Abingdon Oxfordshire, United Kingdom. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated July 30, 2008. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015492990
- Address
- 143 Park Drive East Milton Park, Abingdon Oxfordshire, United Kingdom, OX14 4SE
- Owner or operator
- Oxford Immunotec Ltd (10026700)
- Roles
- Manufacturer
- First device listed
- August 13, 2008
- Registered through
- 2026
- Brand names listed
- T-Cell Select reagent, T-Cell Xtend reagent, T-SPOT.TB Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Culture Media, Enriched | KZI | 1 | Manufacturer | accessdata.fda.gov |
| Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test | OJN | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 30, 2008 | P070006 | T SPOT-TB TEST | OJN | 27 | August 4, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 7, 2022 | 90654 | Class II | Ongoing | T-SPOT.TB REF TB.300 US | Due to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time. | accessdata.fda.gov |
Compare with other makers
Updated August 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.