Qualitative Antibody IgM Control Material for Rubella Virus Testing - Vietnam Registration 2403745ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative Antibody IgM Control Material for Rubella Virus Testing 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 2403745ĐKLH/BYT-HTTB and manufactured by Abbott Ireland Diagnostics Division. 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
2403745ĐKLH/BYT-HTTB
000.00.04.G18-231208-0058
ARCHITECT Rubella IgM Controls
6C18-13
Technical Details
The ARCHITECT Rubella IgM Controls material is used to assess the accuracy of the test and to detect systematic analysis deviation of the ARCHITECT iSystem when performing qualitative detection of Rubella virus IgM antibodies in human serum and plasma. Refer to the ARCHITECT Rubella IgM Assay User Manual and the ARCHITECT System Operations Manual for additional information.
Dates and Status
Nov 19, 2024