CHANGCHUN WANCHENG BIO ELECTRON · 89-08 · CHINA

For CHANGCHUN WANCHENG BIO ELECTRON · 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 COVIDEX-AB2 | Biopolygen's COVID-19 Antibody Screening Test | COVIDEX-AB2 | Biopolygen's COVID-19 Antibody Screening Test; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 03/12/2021; address is NO 789 Shunda Road Chan , Changchun, CHINA, verified against its source on 2026-09-16.

What the source says

CHANGCHUN WANCHENG BIO ELECTRON Date Published : 03/12/2021 NO 789 Shunda Road Chan , Changchun, CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 03/12/2021 Desc: COVIDEX-AB2 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 03/12/2021 Desc: Biopolygen's COVID-19 Antibody Screening Test 83 Q - - KO Reagent, coronavirus serological Date Published: 03/12/2021 Desc: COVIDEX-AB2 83 Q - - KO Reagent, coronavirus serological Date Published: 03/12/2021 Desc: Biopolygen's COVID-19 Antibody Screening 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.