Panion & BF Biotech Inc. · 89-08 · TAIWAN
For Panion & BF Biotech Inc. · 89-08 · TAIWAN, 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 TAIWAN; product is Vstrip COVID-19 Antigen Rapid Test; product code is 83 Q - - KP Coronavirus antigen detection test system; date published is 05/28/2021; address is 16 F , 3 Park St.; Nan Gang Qushi , Tai Bei Shi, TAIWAN, verified against its source on 2026-09-16.
- Firm
- Panion & BF Biotech 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
- TAIWAN verified
- Address
- 16 F , 3 Park St.; Nan Gang Qushi , Tai Bei Shi, TAIWAN verified
- Date published
- 05/28/2021 verified
- Product code
- 83 Q - - KP Coronavirus antigen detection test system. verified
- Product
- Vstrip COVID-19 Antigen Rapid Test verified
What the source says
Panion & BF Biotech Inc. Date Published : 05/28/2021 16 F , 3 Park St.; Nan Gang Qushi , Tai Bei Shi, TAIWAN 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/28/2021 Desc: Vstrip COVID-19 Antigen Rapid Test
— 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.