# INZEK INTERNATIONAL TRADING · 89-08 · NETHERLANDS — FDA import alert red lists: firms subject to detention without physical examination

For INZEK INTERNATIONAL TRADING · 89-08 · NETHERLANDS, 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 NETHERLANDS; product is BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502) | Biozek COVID-19 Antigen Rapid Test Cassette | Biozek Antigen Rapid Test; product code is 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 05/04/2021; address is Vissenstraat 32 , Apeldoorn, Gelderland NETHERLANDS, verified against its source on 2026-09-16.

- **Firm:** INZEK INTERNATIONAL TRADING _(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:** NETHERLANDS _(verified: appears in the quote below)_
- **Address:** Vissenstraat 32 , Apeldoorn, Gelderland NETHERLANDS _(verified: appears in the quote below)_
- **Date published:** 05/04/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502) | Biozek COVID-19 Antigen Rapid Test Cassette | Biozek Antigen Rapid Test _(verified: each item appears in the quote below)_

## What the source says

> INZEK INTERNATIONAL TRADING Date Published : 05/04/2021 Vissenstraat 32 , Apeldoorn, Gelderland NETHERLANDS 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/04/2021 Desc: Biozek COVID-19 Antigen Rapid Test Cassette 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/04/2021 Desc: Biozek Antigen Rapid Test

## 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/).