This page includes the latest FDA filings for Medicalsystem Biotechnology Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| CHINA | SHENZHEN STOCK EXCHANGE | 300439 | DUNS 545261989 |
| Registration Number | 3013654096 |
| FEI Number | 3013654096 |
| Name | MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. |
| Owner & Operator | MedicalSystem Biotechnology Co., Ltd. |
| Contact Address | No.299, Qiming South Road, Yinzhou Distr Ningbo CN-33 Zhejiang 315104 CN |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | No.299, Qiming South Road, Yinzhou District, 315104 Ningbo, Chin Ningbo Zhejiang, 315104 CN |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. | Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | 2020-03-25 |
MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. | SARS-CoV-2 RT-PCR Test Kit | 2020-03-25 |
MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. | Coronavirus Disease 2019 Real Time PCR Kit | 2020-03-25 |
MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. | Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit | 2020-03-25 |
| Medicalsystem Biotechnology Co., Ltd. | Microalbuminuria Kit (Immunoturbidimetric Method) | 2019-03-15 |
| Medicalsystem Biotechnology Co., Ltd. | β2-Microglobin Kit (Latex-Enhanced Immunoturbidim | 2019-03-15 |
| Medicalsystem Biotechnology Co., Ltd. | Total Protein Kit (Biuret Method) (2-Part Reagents | 2019-03-15 |
| Medicalsystem Biotechnology Co., Ltd. | Total Protein Kit (Biuret Method) | 2019-03-15 |
| Medicalsystem Biotechnology Co., Ltd. | Lactate Dehydrogenase Isozyme 1 Kit (Kinetic Metho | 2019-03-15 |
| Medicalsystem Biotechnology Co., Ltd. | Lactate Dehydrogenase Kit (Kinetic Method) | 2019-03-15 |
| Medicalsystem Biotechnology Co., Ltd. | Haptoglobin Kit (Immunoturbidimetric Method) | 2019-03-15 |
| Medicalsystem Biotechnology Co., Ltd. | Aspartate Aminotransferase Kit (Colorimetric Metho | 2019-03-15 |
MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. | Total Cholesterol Kit (CHOD-PAP Method) | 2017-08-10 |