CHANGCHUN WANCHENG BIO ELECTRON · 89-08 · CHINA
For CHANGCHUN WANCHENG BIO ELECTRON, import alert is 89-08; country is CHINA; 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)"; 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 2026-09-30.
- Firm
- CHANGCHUN WANCHENG BIO ELECTRON 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
- NO 789 Shunda Road Chan , Changchun, CHINA verified
- Date published
- 03/12/2021 verified
- Product code
- 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 each item verified
- Product
- COVIDEX-AB2 | Biopolygen's COVID-19 Antibody Screening Test | COVIDEX-AB2 | Biopolygen's COVID-19 Antibody Screening Test each item verified
What the source says
CHANGCHUN WANCHENG BIO ELECTRON Date Published : 03/12/2021 NO 789 Shunda Road Chan , Changchun, CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html