Biocartis Nv · 89-08 · BELGIUM
For Biocartis Nv · 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 SeptiCyte RAPID; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 12/07/2021; address is B 3 , Generaal De Wittelaan 11 , Mechelen, Antwerp BELGIUM, verified against its source on 2026-09-16.
- Firm
- Biocartis Nv 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
- B 3 , Generaal De Wittelaan 11 , Mechelen, Antwerp BELGIUM verified
- Date published
- 12/07/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- SeptiCyte RAPID verified
What the source says
Biocartis Nv Date Published : 12/07/2021 B 3 , Generaal De Wittelaan 11 , Mechelen, Antwerp BELGIUM 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 12/07/2021 Desc: SeptiCyte RAPID
— 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.