IVD Department Qualitative IgM Antibody Test for Rubella Virus
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Oct 22, 2024- Analysis ID
- 2402946ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230905-0006
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI
- Intended Use
- 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.
- Registration Date
- Oct 22, 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 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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