# VIVACHEK BIOTECH (HANGZHOU) CO LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **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: appears in the quote below)_
- **Date published:** 01/11/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological _(verified: each item appears in the quote below)_
- **Product:** VivaDiag COVID-19 IgM/IgG Rapid Test | VivaDiag COVID-10 IgM/IgG Rapid Test _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).