INZEK INTERNATIONAL TRADING · 89-08 · NETHERLANDS
For INZEK INTERNATIONAL TRADING, import alert is 89-08; country is NETHERLANDS; 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)"; product is Biozek COVID-19 Antigen Rapid Test Cassette | Biozek Antigen Rapid Test | BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502); 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 2026-09-30.
- Firm
- INZEK INTERNATIONAL TRADING 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
- Vissenstraat 32 , Apeldoorn, Gelderland NETHERLANDS verified
- Date published
- 05/04/2021 verified
- 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. each item verified
- Product
- Biozek COVID-19 Antigen Rapid Test Cassette | Biozek Antigen Rapid Test | BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502) each item verified
What the source says
INZEK INTERNATIONAL TRADING Date Published : 05/04/2021 Vissenstraat 32 , Apeldoorn, Gelderland NETHERLANDS
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
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 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/04/2022 Desc: BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502)
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html