# ZHEJIANG GENE SCIENCE CO., LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For ZHEJIANG GENE SCIENCE 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 Novel Coronavirus (2019nCov) IgM/IgG Antibodies Detection Kit (Latex Chromatography) | Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography); product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2021; address is No. 2 Workshop, Pharmaceutical Industrial Park, No. 11 Shengxing Road, Shangyu Economic And Technological Dev , Shaoxing, Zhejiang CHINA, verified against its source on 2026-09-16.

- **Firm:** ZHEJIANG GENE SCIENCE 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. 2 Workshop, Pharmaceutical Industrial Park, No. 11 Shengxing Road, Shangyu Economic And Technological Dev , Shaoxing, Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 06/22/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. _(verified: each item appears in the quote below)_
- **Product:** Novel Coronavirus (2019nCov) IgM/IgG Antibodies Detection Kit (Latex Chromatography) | Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography) _(verified: each item appears in the quote below)_

## What the source says

> ZHEJIANG GENE SCIENCE CO., LTD Date Published : 06/22/2021 No. 2 Workshop, Pharmaceutical Industrial Park, No. 11 Shengxing Road, Shangyu Economic And Technological Dev , Shaoxing, Zhejiang CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 04/19/2022 Desc: Novel Coronavirus (2019nCov) IgM/IgG Antibodies Detection Kit (Latex Chromatography) 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2021 Desc: Novel Coronavirus (COVID-19) Antigen Detection Kit (Latex Immunochromatography)

## 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/).