INZEK INTERNATIONAL TRADING BV · 89-08 · NETHERLANDS
For INZEK INTERNATIONAL TRADING BV, 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 (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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
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: 04/04/2022 Desc: BIOZEK COVID-19 Antigen Rapid Test Cassette (PC; BCOV-502)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html