VIVACHEK BIOTECH (HANGZHOU) CO, ltd. · 89-08 · CHINA (Yuhang , 1/2/3 F, Building 1, 16 East Zhenxing Rd.; Economy Development Zone , Hangzhou, Zhejiang CHINA)

For VIVACHEK BIOTECH (HANGZHOU) CO, ltd. (Yuhang , 1/2/3 F, Building 1, 16 East Zhenxing Rd.; Economy Development Zone , Hangzhou, Zhejiang CHINA), 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 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 2026-09-30.

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

— accessdata.fda.gov, retrieved 2026-09-22

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.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.