Panion & BF Biotech Inc. · 89-08 · TAIWAN
For Panion & BF Biotech Inc., import alert is 89-08; country is TAIWAN; 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 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 2026-09-30.
- 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
— 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: 05/28/2021 Desc: Vstrip COVID-19 Antigen Rapid Test
— 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.