Changchun Wancheng Bio-Electron Co., Ltd. · 89-08 · CHINA
For Changchun Wancheng Bio-Electron 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 COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography) | nanoMedicina SARS-COV-2 IgM/IgG ANTIBODY RAPID TEST KIT | COVIDEX-AB2 | COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography) | Biopolygen's COVID-19 Antibody Screening Test | COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography); product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 06/23/2020; address is 2336, Tianwei Road , Beihu Science and Technology Development Zone , Changchun, Jilin CHINA, verified against its source on 2026-09-16.
- Firm
- Changchun Wancheng Bio-Electron 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
- 2336, Tianwei Road , Beihu Science and Technology Development Zone , Changchun, Jilin CHINA verified
- Date published
- 06/23/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography) | nanoMedicina SARS-COV-2 IgM/IgG ANTIBODY RAPID TEST KIT | COVIDEX-AB2 | COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography) | Biopolygen's COVID-19 Antibody Screening Test | COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography) each item verified
What the source says
Changchun Wancheng Bio-Electron Co., Ltd. Date Published : 06/23/2020 2336, Tianwei Road , Beihu Science and Technology Development Zone , Changchun, Jilin CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 06/23/2020 Desc: COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography) 83 Q - - KO Reagent, coronavirus serological Date Published: 01/11/2021 Desc: nanoMedicina SARS-COV-2 IgM/IgG ANTIBODY RAPID TEST KIT 83 Q - - KO Reagent, coronavirus serological Date Published: 03/23/2021 Desc: COVIDEX-AB2 83 Q - - KO Reagent, coronavirus serological Date Published: 06/23/2020 Desc: COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography) 83 Q - - KO Reagent, coronavirus serological Date Published: 03/23/2021 Desc: Biopolygen's COVID-19 Antibody Screening Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 06/23/2020 Desc: COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html