IVD Department Qualitative IgM Antibody Test for Rubella Virus - Vietnam Registration 2403711ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2403711ĐKLH/BYT-HTTB
17005531/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
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.
Dates and Status
Nov 19, 2024