Quantitative Antibody Test for IgM against the Core Antigen of Hepatitis B Virus (anti-HBc IgM) - Vietnam Registration 2400827ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Quantitative Antibody Test for IgM against the Core Antigen of Hepatitis B Virus (anti-HBc IgM) 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 2400827ĐKLH/BYT-HTTB and manufactured by BIOMERIEUX SA. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM.
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Device Details
Registration Details
2400827ĐKLH/BYT-HTTB
17002407/ĐKLH-BYT-TB-CT
VIDAS® HBc IgM II
30439
Technical Details
VIDAS® HBc IgM II is an automated quantitative test intended for use on VIDAS® devices to determine the presence of IgM antibodies against the core antigen of the hepatitis B virus (anti-HBc IgM) in human serum or plasma (EDTA, citrate and lithium heparin), using the ELFA (Enzyme-Linked Fluorescence Assay) technique. It is intended to be used in combination with the total anti-HBc antibody test to detect the presence of IgM antibodies against HBc in individuals suspected of being infected with the hepatitis B virus, thereby aiding in the diagnosis of hepatitis B virus infection.
Dates and Status
Jun 24, 2024