# Hangzhou Ausia Biological Tech. Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Hangzhou Ausia Biological Tech. 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 test kit; product code is 82 M - - ZF Test, HIV Detection; date published is 02/03/2012; address is No. 1 First Rd, Hetz , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-16.

- **Firm:** Hangzhou Ausia Biological Tech. 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. 1 First Rd, Hetz , Hangzhou, Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 02/03/2012 _(verified: appears in the quote below)_
- **Product code:** 82 M - - ZF Test, HIV Detection _(verified: appears in the quote below)_
- **Product:** HIV test kit _(verified: appears in the quote below)_
- **FDA notes:** class II _(verified: appears in the quote below)_

## What the source says

> Hangzhou Ausia Biological Tech. Co., Ltd Date Published : 02/03/2012 No. 1 First Rd, Hetz , Hangzhou, Zhejiang CHINA 82 M - - ZF Test, HIV Detection Date Published: 02/03/2012 Desc: HIV test kit Notes: class II

## 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/).