IVD Department quantitative IgG antibody against CMV - Vietnam Registration 2400528ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative IgG antibody against CMV 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 2400528ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.
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Device Details
Registration Details
2400528ĐKLH/BYT-HTTB
18006229/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
LIAISON CMV IgG II: The LIAISON CMV IgG II test uses the CLIA (Chemiluminescent Immunoassay) technology to quantify the specific IgG antibodies against hCMV (Human Cytomegalovirus) in human serum or plasma samples. It is performed on the LIAISON automated immunoassay analyzer. LIAISON Control CMV IgG II: The LIAISON Control CMV IgG II (negative and positive controls) are used in the CLIA (Chemiluminescent Immunoassay) LIAISON test to assess the reliability of the test runs. The performance characteristics of the LIAISON Control CMV IgG II controls are not established for any other test or system other than the LIAISON, LIAISON XL and LIAISON XS immunoassay analyzers.
Dates and Status
Apr 10, 2024