# Biocartis Nv · 89-08 · BELGIUM — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** B 3 , Generaal De Wittelaan 11 , Mechelen, Antwerp BELGIUM _(verified: appears in the quote below)_
- **Date published:** 12/07/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid _(verified: appears in the quote below)_
- **Product:** SeptiCyte RAPID _(verified: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).