Hangzhou Ausia Biological Tech. Co., Ltd · 89-08 · CHINA
For Hangzhou Ausia Biological Tech. Co., Ltd, import alert is 89-08; country is CHINA; 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 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 2026-09-30.
- 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
— 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, Product and FDA notes
82 M - - ZF Test, HIV Detection Date Published: 02/03/2012 Desc: HIV test kit Notes: class II
— 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.