Coris Bioconcept · 89-08 · BELGIUM
For Coris Bioconcept, import alert is 89-08; country is BELGIUM; 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 Covelex | CoV-2 Rapid Antigen Test; product code is 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/27/2021; address is Rue Jean Sonet 4a , Isnes, Namur BELGIUM, verified against its source on 2026-09-30.
- Firm
- Coris Bioconcept 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
- BELGIUM verified
- Address
- Rue Jean Sonet 4a , Isnes, Namur BELGIUM verified
- Date published
- 07/27/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- Covelex | CoV-2 Rapid Antigen Test each item verified
What the source says
Coris Bioconcept Date Published : 07/27/2021 Rue Jean Sonet 4a , Isnes, Namur BELGIUM
— 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: 07/27/2021 Desc: Covelex 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: CoV-2 Rapid Antigen Test
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html