BIOSYNEX · 89-08 · FRANCE
For BIOSYNEX, 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 Biosynex COVID19 BSS; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 04/20/2022; address is 22 Boulevard Sebastien Brant , Illkirch Graffenstaden, Bas Rhin FRANCE, verified against its source on 2026-09-30.
- Firm
- BIOSYNEX 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
- 22 Boulevard Sebastien Brant , Illkirch Graffenstaden, Bas Rhin FRANCE verified
- Date published
- 04/20/2022 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- Biosynex COVID19 BSS verified
What the source says
BIOSYNEX Date Published : 04/20/2022 22 Boulevard Sebastien Brant , Illkirch Graffenstaden, Bas Rhin FRANCE
— accessdata.fda.gov, retrieved 2026-09-15
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: 04/20/2022 Desc: Biosynex COVID19 BSS
— all from 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.