IVD Department Qualitative Antibody Test for HDV - Vietnam Registration 2400634ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Qualitative Antibody Test for HDV in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2400634ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.
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Device Details
Registration Details
2400634ĐKLH/BYT-HTTB
19010414/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
LIAISON XL murex Anti-HDV: The LIAISON XL murex Anti-HDV test uses the CLIA (Chemiluminescent Immunoassay) technology to determine the presence of antibodies against the hepatitis D virus (anti-HDV) in human serum and plasma samples, including samples obtained post-mortem (after cardiac arrest). The test is used to support the diagnosis of hepatitis D infection in individuals, whether symptomatic or asymptomatic. It is also used for screening of organ, tissue, or cell donors after death. The test is performed only on the LIAISON automated immunoassay instrument. LIAISON XL murex Control Anti-HDV: The LIAISON XL murex Control Anti-HDV (negative and positive controls) are used for CLIA (Chemiluminescent Immunoassay) LIAISON tests to assess the reliability of test runs. The performance characteristics of the LIAISON XL murex Control Anti-HDV controls have not been established for any other test or device except the LIAISON automated immunoassay instrument.
Dates and Status
May 10, 2024