Shanghai Eugene Biotech Co Ltd · 89-08 · CHINA

For Shanghai Eugene Biotech 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 SARS-CoV2 (COVID-19) IgG/IgM Rapid Test | SARS-CoV2 (COVID-19) IgG/IgM Rapid Test | SARS-CoV2 (COVID-19) IgG/IgM Rapid Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/22/2020; address is Runcai Intelligent Industrial Park , Fengxian , Shanghai, Shanghai CHINA, verified against its source on 2026-09-16.

Firm: Shanghai Eugene Biotech Co Ltd 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: Runcai Intelligent Industrial Park , Fengxian , Shanghai, Shanghai CHINA verified
Date published: 06/22/2020 verified
Product code: 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
Product: SARS-CoV2 (COVID-19) IgG/IgM Rapid Test | SARS-CoV2 (COVID-19) IgG/IgM Rapid Test | SARS-CoV2 (COVID-19) IgG/IgM Rapid Test each item verified

Sourceaccessdata.fda.gov

Verified2026-09-16

Review by2026-11-15

DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Shanghai Eugene Biotech Co Ltd Date Published : 06/22/2020 Runcai Intelligent Industrial Park , Fengxian , Shanghai, Shanghai CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/22/2020 Desc: SARS-CoV2 (COVID-19) IgG/IgM Rapid Test 83 Q - - KO Reagent, coronavirus serological Date Published: 06/22/2020 Desc: SARS-CoV2 (COVID-19) IgG/IgM Rapid Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/22/2020 Desc: SARS-CoV2 (COVID-19) IgG/IgM Rapid Test

— accessdata.fda.gov, retrieved 2026-09-15

Source

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

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.

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.

Shanghai Eugene Biotech Co Ltd · 89-08 · CHINA

What the source says

Source

More on food, drink and consumer products