Wuhan Life Origin Biotech Joint Stock Co., Ltd. · 89-08 · CHINA
For Wuhan Life Origin Biotech Joint Stock 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-CoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography) | Szybio Life Origin Biotech SARS-SoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography); product code is 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological; date published is 04/15/2021; address is Wuhan Hi-Tech Medical Devices Park, Building B11, #818 Gaoxin Road, Donghu Hi , Tech Development Area , Wuhan, Hubei CHINA, verified against its source on 2026-09-16.
- Firm
- Wuhan Life Origin Biotech Joint Stock 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
- Wuhan Hi-Tech Medical Devices Park, Building B11, #818 Gaoxin Road, Donghu Hi , Tech Development Area , Wuhan, Hubei CHINA verified
- Date published
- 04/15/2021 verified
- Product code
- 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological each item verified
- Product
- SARS-CoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography) | Szybio Life Origin Biotech SARS-SoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography) each item verified
What the source says
Wuhan Life Origin Biotech Joint Stock Co., Ltd. Date Published : 04/15/2021 Wuhan Hi-Tech Medical Devices Park, Building B11, #818 Gaoxin Road, Donghu Hi , Tech Development Area , Wuhan, Hubei CHINA 83 Q - - KO Reagent, coronavirus serological Date Published: 04/15/2021 Desc: SARS-CoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography) 83 Q - - KO Reagent, coronavirus serological Date Published: 04/15/2021 Desc: Szybio Life Origin Biotech SARS-SoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html