Reference Source

Coris Bioconcept · 89-08 · BELGIUM

For Coris Bioconcept · 89-08 · BELGIUM, 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 BELGIUM; product is CoV-2 Rapid Antigen Test | Covelex; 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 2026-09-16.

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
CoV-2 Rapid Antigen Test | Covelex each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Coris Bioconcept Date Published : 07/27/2021 Rue Jean Sonet 4a , Isnes, Namur BELGIUM 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: CoV-2 Rapid Antigen Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/27/2021 Desc: Covelex

accessdata.fda.gov, retrieved 2026-09-15

Source

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