# Kappa City Biotech SAS · 89-08 · FRANCE — FDA import alert red lists: firms subject to detention without physical examination

For Kappa City Biotech SAS · 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 Urine Test Strip; product code is 91 M - - GX Test System, for Drugs of Abuse; date published is 01/24/2018; address is 32 Rue Danton , Montlucon, Allier FRANCE, verified against its source on 2026-09-16.

- **Firm:** Kappa City Biotech SAS _(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:** FRANCE _(verified: appears in the quote below)_
- **Address:** 32 Rue Danton , Montlucon, Allier FRANCE _(verified: appears in the quote below)_
- **Date published:** 01/24/2018 _(verified: appears in the quote below)_
- **Product code:** 91 M - - GX Test System, for Drugs of Abuse _(verified: appears in the quote below)_
- **Product:** Urine Test Strip _(verified: appears in the quote below)_

## What the source says

> Kappa City Biotech SAS Date Published : 01/24/2018 32 Rue Danton , Montlucon, Allier FRANCE 91 M - - GX Test System, for Drugs of Abuse Date Published: 01/24/2018 Desc: Urine Test Strip

## 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/).