SHANGHAI LIANGRUN BIOMEDICINE TECHNOLOGY CO., LTD · 89-08 · CHINA

For SHANGHAI LIANGRUN BIOMEDICINE TECHNOLOGY 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 Liangrun COVID-19 IgM/IgG Antibody Test | Diagnostic Kit for Detection of COVID-19 Antibodies (IgG/IgM) | Liangrun COVID-19 IgM/IgG Antibody Test | Liangrun COVID-19 IgM/IgG Antibody Test | Liangrun COVID-19 IgM/IgG Antibody Test; product code is 83 O - - TG Non-sars coronavirus multiplex nucleic acid assay | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. | 83 Q - - MN COVID-19 Multi-Analyte Antigen Device; date published is 04/15/2021; address is Level 4 , Building 1 , No. 271 Gang'Ao Road, Pilot Free Trade Zone , Shanghai, Shanghai CHINA, verified against its source on 2026-09-30.

What the source says

SHANGHAI LIANGRUN BIOMEDICINE TECHNOLOGY CO., LTD Date Published : 04/15/2021 Level 4 , Building 1 , No. 271 Gang'Ao Road, Pilot Free Trade Zone , Shanghai, Shanghai 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.