BTNX Inc. · 89-08 · CANADA
For BTNX Inc., import alert is 89-08; country is CANADA; 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 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 2026-09-30.
- 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
— 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: 06/22/2021 Desc: Rapid Response COVID-19 Antigen Rapid Test Device
— all from 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.