# Panion & BF Biotech Inc. · 89-08 · TAIWAN — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 16 F , 3 Park St.; Nan Gang Qushi , Tai Bei Shi, TAIWAN _(verified: appears in the quote below)_
- **Date published:** 05/28/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KP Coronavirus antigen detection test system. _(verified: appears in the quote below)_
- **Product:** Vstrip COVID-19 Antigen Rapid Test _(verified: appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).