Vietnam MOH registration 2402537ĐKLH/BYT-HTTB

Qualitative/Quantitative Assay for IgM Antibodies Against Cytomegalo Virus

VN: Bộ xét nghiệm định tính/định lượng kháng thể IgM kháng vi rút Cytomegalo

Vietnam·Risk Class TTBYT Loại C·SERION ELISA classic Cytomegalovirus IgM·Institut Virion\Serion GmbH·Registered Aug 30, 2024

Registration details

Analysis ID: 2402537ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220504-0106
Product Type: SERION ELISA classic Cytomegalovirus IgM
Product Code: ESR109M

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 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

Registration Date: Aug 30, 2024

About this record

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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