BIOSPEEDIA SAS · 89-08 · FRANCE
For BIOSPEEDIA SAS, import alert is 89-08; country is FRANCE; 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 COVID19SEROSpeed-lgM-lgG Rapid IgG/IgM Test | COVID19 Speed Test Strip; 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 2026-09-30.
- 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
- COVID19SEROSpeed-lgM-lgG Rapid IgG/IgM Test | COVID19 Speed Test Strip each item verified
What the source says
BIOSPEEDIA SAS Date Published : 08/30/2021 25 Rue Du Docteur Roux , Paris, Paris FRANCE
— 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: COVID19SEROSpeed-lgM-lgG Rapid IgG/IgM Test 83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: COVID19 Speed Test Strip
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html