IVD Department quantitative IgM specific antibody test for Toxoplasma gondii - Vietnam Registration 2400527ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative IgM specific antibody test for Toxoplasma gondii 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 2400527ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.
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Device Details
Registration Details
2400527ĐKLH/BYT-HTTB
18007033/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
LIAISON Toxo IgM: The LIAISON Toxo IgM test uses the CLIA (Chemiluminescent Immunoassay) technology to quantify the specific IgM antibodies against Toxoplasma gondii in human serum or plasma samples. The test is performed on the LIAISON automated immunoassay analyzer. LIAISON Control Toxo IgM: The LIAISON Control Toxo IgM (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 Toxo IgM control material have not been established for any other test or system except the LIAISON, LIAISON XL and LIAISON XS automated immunoassay analyzers.
Dates and Status
Apr 10, 2024