ZenTech SA · 89-08 · BELGIUM
For ZenTech SA · 89-08 · BELGIUM, 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 BELGIUM; product is QuickZen COVID-19 IgM / IgG; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 03/02/2021; address is Avenue Pre-Aily 10 , Lige Science Park , Liege, Liege BELGIUM, verified against its source on 2026-09-16.
- Firm
- ZenTech SA 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
- BELGIUM verified
- Address
- Avenue Pre-Aily 10 , Lige Science Park , Liege, Liege BELGIUM verified
- Date published
- 03/02/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- QuickZen COVID-19 IgM / IgG verified
What the source says
ZenTech SA Date Published : 03/02/2021 Avenue Pre-Aily 10 , Lige Science Park , Liege, Liege BELGIUM 83 Q - - KO Reagent, coronavirus serological Date Published: 03/02/2021 Desc: QuickZen COVID-19 IgM / IgG
— 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.