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 | VivaDiag COVID-10 IgM/IgG Rapid Test; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 01/11/2021; address is No.17 Wuzhou Road, Donghu Street, Linping District, Hangzhou, 311100 Building 2 and Building 3, No.17 Jianxing , Road, Taozhu Street, Zhuji, 311800 , Hangzhou, Zhuji 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
- No.17 Wuzhou Road, Donghu Street, Linping District, Hangzhou, 311100 Building 2 and Building 3, No.17 Jianxing , Road, Taozhu Street, Zhuji, 311800 , Hangzhou, Zhuji Zhejiang CHINA verified
- Date published
- 01/11/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- VivaDiag COVID-19 IgM/IgG Rapid Test | VivaDiag COVID-10 IgM/IgG Rapid Test each item verified
What the source says
VIVACHEK BIOTECH (HANGZHOU) CO LTD Date Published : 01/11/2021 No.17 Wuzhou Road, Donghu Street, Linping District, Hangzhou, 311100 Building 2 and Building 3, No.17 Jianxing , Road, Taozhu Street, Zhuji, 311800 , Hangzhou, Zhuji Zhejiang CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 01/26/2021 Desc: VivaDiag COVID-19 IgM/IgG Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 01/11/2021 Desc: VivaDiag COVID-10 IgM/IgG Rapid Test
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html