INZEK INTERNATIONAL TRADING BV · 89-08 · NETHERLANDS
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
- 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
- Address
- B. V. Laan Van De Ram 4 , Apeldoorn, NETHERLANDS verified
- Date published
- 04/04/2022 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502) verified
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)
— 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.