Oxford Immunotec · 89-08 · UNITED KINGDOM
For Oxford Immunotec, import alert is 89-08; country is UNITED KINGDOM; 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)"; product is T-SPOT.COVID | T cell ELISPOT test for SARS-CoV-2; 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 2026-09-30.
- Firm
- Oxford Immunotec verified
- 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
- Address
- 94c Innovation Drive , Abingdon, Oxfordshire UNITED KINGDOM verified
- Date published
- 08/30/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- T-SPOT.COVID | T cell ELISPOT test for SARS-CoV-2 each item verified
What the source says
Oxford Immunotec Date Published : 08/30/2021 94c Innovation Drive , Abingdon, Oxfordshire UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: T-SPOT.COVID 83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: T cell ELISPOT test for SARS-CoV-2
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html