SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE CO. LTD. · 89-08 · CHINA
For SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE 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 Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit | Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit | Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system; date published is 07/07/2020; address is No. 830 Chenyin Rd. , District , Baoshan, Shanghai CHINA, verified against its source on 2026-09-16.
- Firm
- SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE 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
- No. 830 Chenyin Rd. , District , Baoshan, Shanghai CHINA verified
- Date published
- 07/07/2020 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid | 83 Q - - KO Reagent, coronavirus serological | 83 Q - - KP Coronavirus antigen detection test system. each item verified
- Product
- Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit | Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit | Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit each item verified
What the source says
SHANGHAI FOSUN LONG MARCH MEDICAL SCIENCE CO. LTD. Date Published : 07/07/2020 No. 830 Chenyin Rd. , District , Baoshan, Shanghai CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 07/07/2020 Desc: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 07/07/2020 Desc: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 07/07/2020 Desc: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html