BTNX Inc. · 89-08 · CANADA
For BTNX Inc. · 89-08 · CANADA, 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 CANADA; product is Rapid Response COVID-19 Antigen Rapid Test Device; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is 722 Rosebank Rd , Pickering, Ontario CANADA, verified against its source on 2026-09-16.
- Firm
- BTNX Inc. 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
- CANADA verified
- Address
- 722 Rosebank Rd , Pickering, Ontario CANADA verified
- Date published
- 06/22/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- Rapid Response COVID-19 Antigen Rapid Test Device verified
What the source says
BTNX Inc. Date Published : 06/22/2021 722 Rosebank Rd , Pickering, Ontario CANADA 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: Rapid Response COVID-19 Antigen Rapid Test Device
— 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.