ZenTech SA · 89-08 · BELGIUM
For ZenTech SA, import alert is 89-08; country is BELGIUM; 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 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 2026-09-30.
- 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
— 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: 03/02/2021 Desc: QuickZen COVID-19 IgM / IgG
— 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.