Hangzhou Biotest Biotech Co.,Ltd. · 89-08 · CHINA
For Hangzhou Biotest Biotech 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 NADAL COVID-19 IgG/IgM Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 08/30/2021; address is # 17 Zhong Tai Lu , Yuhangqu , Hangzhou City, Zhejiangsheng CHINA, verified against its source on 2026-09-30.
- Firm
- Hangzhou Biotest Biotech 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
- # 17 Zhong Tai Lu , Yuhangqu , Hangzhou City, Zhejiangsheng CHINA verified
- Date published
- 08/30/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- NADAL COVID-19 IgG/IgM Test verified
What the source says
Hangzhou Biotest Biotech Co.,Ltd. Date Published : 08/30/2021 # 17 Zhong Tai Lu , Yuhangqu , Hangzhou City, Zhejiangsheng 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 and Product
83 Q - - KO Reagent, coronavirus serological Date Published: 08/30/2021 Desc: NADAL COVID-19 IgG/IgM Test
— 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.