Qualitative/Quantitative Assay for IgM Antibodies Against Cytomegalo Virus - Vietnam Registration 2402537ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative/Quantitative Assay for IgM Antibodies Against Cytomegalo Virus 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 2402537ĐKLH/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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Device Details
Registration Details
2402537ĐKLH/BYT-HTTB
000.00.04.G18-220504-0106
SERION ELISA classic Cytomegalovirus IgM
ESR109M
Technical Details
The SERION ELISA classic Cytomegalovirus IgM test is a qualitative and quantitative immunoassay to detect antibodies in the blood or serum of humans against Cytomegalovirus. The SERION ELISA classic Cytomegalovirus IgM test is recommended for the detection of acute infections. IgM antibodies against Cytomegalovirus are often detected in cases of polyclonal activation and can persist for a long time. The SERION ELISA classic Cytomegalovirus IgM test is suitable for newborn screening with dried blood spots (DBS)
Dates and Status
Aug 30, 2024