# Zhejiang Orient Gene Biotech · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Zhejiang Orient Gene Biotech · 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 COVID-19 Antigen | COVID-19 Antigen | COVID-19 Antigen; product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LW COVID-19 test home collection kit devices; date published is 05/28/2021; address is 3787 East Yangguang Avenue Dipu Street, Anji , Huzhou, Zhejiang CHINA, verified against its source on 2026-09-16.

- **Firm:** Zhejiang Orient Gene Biotech _(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:** 3787 East Yangguang Avenue Dipu Street, Anji , Huzhou, Zhejiang CHINA _(verified: appears in the quote below)_
- **Date published:** 05/28/2021 _(verified: appears in the quote below)_
- **Product code:** 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - LW COVID-19 test home collection kit devices _(verified: each item appears in the quote below)_
- **Product:** COVID-19 Antigen | COVID-19 Antigen | COVID-19 Antigen _(verified: each item appears in the quote below)_

## What the source says

> Zhejiang Orient Gene Biotech Date Published : 05/28/2021 3787 East Yangguang Avenue Dipu Street, Anji , Huzhou, Zhejiang CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 02/10/2023 Desc: COVID-19 Antigen 83 Q - - KP Coronavirus antigen detection test system. Date Published: 05/28/2021 Desc: COVID-19 Antigen 83 Q - - LW COVID-19 test home collection kit devices Date Published: 02/10/2023 Desc: COVID-19 Antigen

## 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/).