BioSure (UK) Limited · 89-08 · UNITED KINGDOM

For BioSure (UK) Limited, 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 BioSURE COVID-19 Antibody Rapid Test | BioSURE COVID-19 Antibody Self Test | BioSURE COVID-19 IgG Antibody Rapid Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 05/14/2021; address is Unit 59 , Hillgrove Business Park; Nazeing Road , Waltham Abbey, Essex UNITED KINGDOM, verified against its source on 2026-09-30.

What the source says

BioSure (UK) Limited Date Published : 05/14/2021 Unit 59 , Hillgrove Business Park; Nazeing Road , Waltham Abbey, Essex 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.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.