BIOSPEEDIA SAS · 89-08 · FRANCE
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
- 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
- Address
- 25 Rue Du Docteur Roux , Paris, Paris FRANCE 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
- COVID19 Speed Test Strip | COVID19SEROSpeed-lgM-lgG Rapid IgG/IgM Test each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.