Quantitative Antibody Test for Measles Virus IgG - Vietnam Registration 2200270ĐKLH/BYT-TB-CT
Access comprehensive regulatory information for Quantitative Antibody Test for Measles Virus IgG 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 2200270ĐKLH/BYT-TB-CT and manufactured by ORGENTEC Diagnostika GmbH.
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Device Details
Registration Details
2200270ĐKLH/BYT-TB-CT
20011507/ĐKLH-BYT-TB-CT
Anti-Measles Virus IgG
ORG 909G
Technical Details
Anti-Measles Virus IgG is used in the ELISA Alegria system to quantify the IgG class antibodies against the measles virus in serum or plasma samples from humans. The product is intended for in vitro diagnostic use by qualified professionals. In routine diagnostic testing, the determination of immunity status is performed by detecting the serological response of specific IgM or IgG antibodies to the virus. Specific IgM antibodies against the virus are crucial for diagnosing acute measles infection. In very rare cases of breakthrough infection after vaccination, the concentration of IgM antibodies may be below the detection limit. In such cases, the seroconversion or significant increase in the concentration of IgG antibodies is useful for confirming the diagnosis. IgG antibodies after measles infection or successful vaccination persist throughout life and the detection of IgG antibodies is used to demonstrate immunity.
Dates and Status
Dec 29, 2022

