IVD Department Qualitative IgM Antibody Test for Rubella Virus
Vietnam·Risk Class TBYT Loại C·Theo theo phụ lục·Beckman Coulter, Inc.·Registered Nov 19, 2024- Analysis ID
- 2403711ĐKLH/BYT-HTTB
- Submission ID
- 17005531/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Beckman Coulter, Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Beckman Coulter, Inc.
- Authorized Representative
- CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG
- Intended Use
- ACCESS Rubella IgM: The Access Rubella IgM test is a fluorescent immunoassay, bead-based test to qualitatively detect IgM antibodies against the Rubella virus in human serum using the Access Immunoassay Systems. ACCESS Rubella IgM CALIBRATORS: Access Rubella IgM Calibrators are used to calibrate the Access Rubella IgM test to qualitatively detect IgM antibodies against the Rubella virus in human serum using the Access Immunoassay Systems. ACCESS Rubella IgM QC: Access Rubella IgM QC is used to monitor the performance of the Access Rubella IgM test system.
- Registration Date
- Nov 19, 2024
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Access comprehensive regulatory information for IVD Department Qualitative IgM Antibody Test for Rubella Virus in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403711ĐKLH/BYT-HTTB and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.
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