Reference Source

BIOSYNEX · 89-08 · FRANCE

For BIOSYNEX · 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 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

BIOSYNEX Date Published : 04/20/2022 22 Boulevard Sebastien Brant , Illkirch Graffenstaden, Bas Rhin FRANCE 83 Q - - KO Reagent, coronavirus serological Date Published: 04/20/2022 Desc: Biosynex COVID19 BSS

accessdata.fda.gov, retrieved 2026-09-15

Source

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

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.