Quantitative/Qualitative IgG Antibody Test for Rubella - Vietnam Registration 2403218ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Quantitative/Qualitative IgG Antibody Test for Rubella 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 2403218ĐKLH/BYT-HTTB and manufactured by Institut Virion\Serion GmbH. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
2403218ĐKLH/BYT-HTTB
17003727/ĐKLH-BYT-TB-CT
SERION ELISA classic for Röteln/Rubella Virus IgG
ESR129G
Technical Details
The SERION ELISA classic Rubella Virus IgG and IgM test is a quantitative and qualitative immunoassay for the detection of human antibodies against the Rubella virus in serum or plasma. The SERION ELISA classic Rubella Virus IgM test allows for the initial detection of acute infection. The SERION ELISA classic Rubella Virus IgG test is used to determine the immune status and to detect the presence of IgG antibodies produced in the bone marrow for diagnosing meningitis. Additionally, the SERION ELISA classic Rubella Virus IgG test determines the affinity of IgG antibodies to distinguish between acute infection and previous infection. The SERION ELISA classic Rubella Virus IgM test is suitable for measuring the amount of specific IgM antibodies in dried blood spots from newborns to detect congenital infection.
Dates and Status
Nov 02, 2024