# Beijing Bioneovan Co.Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Beijing Bioneovan Co.Ltd · 89-08 · CHINA, 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 CHINA; product is HIV Rapid Test; product code is 82 M - - ZF Test, HIV Detection; date published is 07/05/2016; address is NO. 18 Keyuanlu , Daxing , Beijing, Beijing CHINA, verified against its source on 2026-09-16.

- **Firm:** Beijing Bioneovan Co.Ltd _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** NO. 18 Keyuanlu , Daxing , Beijing, Beijing CHINA _(verified: appears in the quote below)_
- **Date published:** 07/05/2016 _(verified: appears in the quote below)_
- **Product code:** 82 M - - ZF Test, HIV Detection _(verified: appears in the quote below)_
- **Product:** HIV Rapid Test _(verified: appears in the quote below)_

## What the source says

> Beijing Bioneovan Co.Ltd Date Published : 07/05/2016 NO. 18 Keyuanlu , Daxing , Beijing, Beijing CHINA 82 M - - ZF Test, HIV Detection Date Published: 07/05/2016 Desc: HIV 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/).