# Oxford Immunotec · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For Oxford Immunotec · 89-08 · UNITED KINGDOM, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is UNITED KINGDOM; product is T cell ELISPOT test for SARS-CoV-2 | T-SPOT.COVID; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 08/30/2021; address is 94c Innovation Drive , Abingdon, Oxfordshire UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** Oxford Immunotec _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** 94c Innovation Drive , Abingdon, Oxfordshire UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 08/30/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** T cell ELISPOT test for SARS-CoV-2 | T-SPOT.COVID _(verified: each item appears in the quote below)_

## What the source says

> Oxford Immunotec Date Published : 08/30/2021 94c Innovation Drive , Abingdon, Oxfordshire UNITED KINGDOM 83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: T cell ELISPOT test for SARS-CoV-2 83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: T-SPOT.COVID

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).