# BIOSPEEDIA SAS · 89-08 · FRANCE — FDA import alert red lists: firms subject to detention without physical examination

For BIOSPEEDIA SAS · 89-08 · FRANCE, 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 FRANCE; product is COVID19 Speed Test Strip | COVID19SEROSpeed-lgM-lgG Rapid IgG/IgM Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 08/30/2021; address is 25 Rue Du Docteur Roux , Paris, Paris FRANCE, verified against its source on 2026-09-16.

- **Firm:** BIOSPEEDIA SAS _(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:** FRANCE _(verified: appears in the quote below)_
- **Address:** 25 Rue Du Docteur Roux , Paris, Paris FRANCE _(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:** COVID19 Speed Test Strip | COVID19SEROSpeed-lgM-lgG Rapid IgG/IgM Test _(verified: each item appears in the quote below)_

## What the source says

> BIOSPEEDIA SAS Date Published : 08/30/2021 25 Rue Du Docteur Roux , Paris, Paris FRANCE 83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: COVID19 Speed Test Strip 83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: COVID19SEROSpeed-lgM-lgG Rapid IgG/IgM Test

## 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/).