Wuhan Life Origin Biotech Joint Stock Co., Ltd. · 89-08 · CHINA

For Wuhan Life Origin Biotech Joint Stock Co., Ltd., 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 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 2026-09-30.

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

— 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.

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

Source

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

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.