Vietnam MOH registration 2403218ĐKLH/BYT-HTTB

Quantitative/Qualitative IgG Antibody Test for Rubella

VN: Bộ xét nghiệm định lượng/định tính kháng thể IgG kháng Rubella

Vietnam·Risk Class TTBYT Loại C·SERION ELISA classic for Röteln/Rubella Virus IgG·Institut Virion\Serion GmbH·Registered Nov 02, 2024

Registration details

Analysis ID: 2403218ĐKLH/BYT-HTTB
Submission ID: 17003727/ĐKLH-BYT-TB-CT
Product Type: SERION ELISA classic for Röteln/Rubella Virus IgG
Product Code: ESR129G

Company information

Manufacturer: Institut Virion\Serion GmbH
Manufacturer Country: GERMANY
Product Owner: Institut Virion\Serion GmbH
Authorized Representative: CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA

Technical details

Intended Use: 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

Registration Date: Nov 02, 2024

About this record

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.

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