# 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; 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: 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:** Yuhang , 1/2/3 F, Building 1, 16 East Zhenxing Rd.; Economy Development Zone , Hangzhou, Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 01/26/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological _(verified: appears in the quote below)_
- **Product:** VivaDiag COVID-19 IgM/IgG Rapid Test _(verified: appears in the quote below)_

## 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

## 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/).