Vietnam MOH registration 2200270ĐKLH/BYT-TB-CT

Quantitative Antibody Test for Measles Virus IgG

VN: Bộ xét nghiệm định lượng kháng thể IgG kháng virus sởi

Vietnam·Risk Class TTBYT Loại C·Anti-Measles Virus IgG·ORGENTEC Diagnostika GmbH·Registered Dec 29, 2022

Registration details

Analysis ID: 2200270ĐKLH/BYT-TB-CT
Submission ID: 20011507/ĐKLH-BYT-TB-CT
Product Type: Anti-Measles Virus IgG
Product Code: ORG 909G

Company information

Manufacturer: ORGENTEC Diagnostika GmbH
Manufacturer Country: GERMANY

Technical details

Intended Use: 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

Registration Date: Dec 29, 2022

About this record

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.

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.