Hangzhou Ausia Biological Tech. Co., Ltd · 89-08 · CHINA
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
- 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
- Address
- No. 1 First Rd, Hetz , Hangzhou, Zhejiang CHINA verified
- Date published
- 02/03/2012 verified
- Product code
- 82 M - - ZF Test, HIV Detection verified
- Product
- HIV test kit verified
- FDA notes
- class II verified
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
— 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.