VIVACHEK BIOTECH (HANGZHOU) CO, ltd. · 89-08 · CHINA
For VIVACHEK BIOTECH (HANGZHOU) 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 VivaDiag COVID-19 IgM/IgG Rapid Test; product code is 83 Q - - KO Reagent, coronavirus serological; date published is 01/26/2021; address is Yuhang , 1/2/3 F, Building 1, 16 East Zhenxing Rd.; Economy Development Zone , Hangzhou, Zhejiang CHINA, verified against its source on 2026-09-16.
- Firm
- VIVACHEK BIOTECH (HANGZHOU) 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
- Yuhang , 1/2/3 F, Building 1, 16 East Zhenxing Rd.; Economy Development Zone , Hangzhou, Zhejiang CHINA verified
- Date published
- 01/26/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological verified
- Product
- VivaDiag COVID-19 IgM/IgG Rapid Test verified
What the source says
VIVACHEK BIOTECH (HANGZHOU) CO, ltd. Date Published : 01/26/2021 Yuhang , 1/2/3 F, Building 1, 16 East Zhenxing Rd.; Economy Development Zone , Hangzhou, Zhejiang CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: VivaDiag COVID-19 IgM/IgG Rapid Test
— 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.