Zhejiang Orient Gene Biotech · 89-08 · CHINA
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
- 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
- Address
- 3787 East Yangguang Avenue Dipu Street, Anji , Huzhou, Zhejiang CHINA verified
- Date published
- 05/28/2021 verified
- 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 each item verified
- Product
- COVID-19 Antigen | COVID-19 Antigen | COVID-19 Antigen each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.