SHANGHAI LIANGRUN BIOMEDICINE TECHNOLOGY CO., LTD · 89-08 · CHINA
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
- 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
- Level 4 , Building 1 , No. 271 Gang'Ao Road, Pilot Free Trade Zone , Shanghai, Shanghai CHINA verified
- Date published
- 04/15/2021 verified
- 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 each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html