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

For INZEK INTERNATIONAL TRADING BV · 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); product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 04/04/2022; address is B. V. Laan Van De Ram 4 , Apeldoorn, NETHERLANDS, verified against its source on 2026-09-16.

- **Firm:** INZEK INTERNATIONAL TRADING BV _(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:** B. V. Laan Van De Ram 4 , Apeldoorn, NETHERLANDS _(verified: appears in the quote below)_
- **Date published:** 04/04/2022 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. _(verified: appears in the quote below)_
- **Product:** BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502) _(verified: appears in the quote below)_

## What the source says

> INZEK INTERNATIONAL TRADING BV Date Published : 04/04/2022 B. V. Laan Van De Ram 4 , Apeldoorn, 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)

## 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/).