# SHANGHAI LIANGRUN BIOMEDICINE TECHNOLOGY CO., LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For SHANGHAI LIANGRUN BIOMEDICINE TECHNOLOGY 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 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 2026-09-16.

- **Firm:** SHANGHAI LIANGRUN BIOMEDICINE TECHNOLOGY CO., LTD _(verified: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Level 4 , Building 1 , No. 271 Gang'Ao Road, Pilot Free Trade Zone , Shanghai, Shanghai CHINA _(verified: appears in the quote below)_
- **Date published:** 04/15/2021 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** 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 _(verified: each item appears in the quote below)_

## 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 83 O - - TG Non-sars coronavirus multiplex nucleic acid assay Date Published: 04/15/2021 Desc: Liangrun COVID-19 IgM/IgG Antibody Test 83 Q - - KO Reagent, coronavirus serological Date Published: 04/15/2021 Desc: Diagnostic Kit for Detection of COVID-19 Antibodies (IgG/IgM) 83 Q - - KO Reagent, coronavirus serological Date Published: 04/15/2021 Desc: Liangrun COVID-19 IgM/IgG Antibody Test 83 Q - - KP Coronavirus antigen detection test system. Date Published: 04/15/2021 Desc: Liangrun COVID-19 IgM/IgG Antibody Test 83 Q - - MN COVID-19 Multi-Analyte Antigen Device Date Published: 04/15/2021 Desc: Liangrun COVID-19 IgM/IgG Antibody Test

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).