MedicalSystem Biotechnology Co., Ltd. · 89-08 · CHINA
For MedicalSystem Biotechnology 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 Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test 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. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices; date published is 10/19/2020; address is No. 299 Qiming South Road , Yinzhou District , Ningbo, Zhejiang CHINA, verified against its source on 2026-09-16.
- Firm
- MedicalSystem Biotechnology 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. 299 Qiming South Road , Yinzhou District , Ningbo, Zhejiang CHINA verified
- Date published
- 10/19/2020 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. | 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices each item verified
- Product
- Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit each item verified
What the source says
MedicalSystem Biotechnology Co., Ltd. Date Published : 10/19/2020 No. 299 Qiming South Road , Yinzhou District , Ningbo, Zhejiang CHINA 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 10/19/2020 Desc: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit 83 Q - - KO Reagent, coronavirus serological Date Published: 10/19/2020 Desc: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit 83 Q - - KP Coronavirus antigen detection test system. Date Published: 10/19/2020 Desc: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit 83 Q - - LT COVID-19 multi-analyte respiratory panel nucleic acid devices Date Published: 10/19/2020 Desc: Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html