IVD Department Qualitative IgM Antibody Test for Rubella Virus - Vietnam Registration 2402946ĐKLH/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 TTBYT Loại C medical device is registered under number 2402946ĐKLH/BYT-HTTB. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.
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Device Details
Registration Details
2402946ĐKLH/BYT-HTTB
000.00.04.G18-230905-0006
Theo theo phụ lục
Theo phụ lục
Technical Details
The Alinity i Rubella IgM calibrator is used to calibrate the Alinity i analyzer when performing qualitative detection of Rubella virus IgM antibodies in human serum and plasma. Refer to the Alinity i Rubella IgM Assay User Manual and the Alinity ci-series Operations Manual. The Alinity i Rubella IgM Controls are used to assess the accuracy of the test and to detect systematic analysis errors of the Alinity i analyzer when performing qualitative detection of Rubella virus IgM antibodies in human serum and plasma. For more information, refer to the Alinity i Rubella IgM Assay User Manual and the Alinity ci-series Operations Manual. The Alinity i Rubella IgM Assay is a fluorescent bead-based immunoassay (CMIA) used to qualitatively detect Rubella virus IgM antibodies in human serum and plasma on the Alinity i system.
Dates and Status
Oct 22, 2024