Vietnam MOH registration 2402927ĐKLH/BYT-HTTB

Quantitative/Qualitative Test Kit for IgM Antibodies Against Toxoplasma gondii

VN: Bộ xét nghiệm định lượng/định tính kháng thể IgM kháng Toxoplasma gondii

Vietnam·Risk Class TTBYT Loại C·SERION ELISA classic Toxoplasma gondii IgM·Institut Virion/Serion GmbH·Registered Oct 22, 2024

Registration details

Analysis ID: 2402927ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220504-0104
Product Type: SERION ELISA classic Toxoplasma gondii IgM
Product Code: ESR110M

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 Toxoplasma gondii IgM test is a quantitative and qualitative immunoassay for detecting human antibodies in serum or plasma against Toxoplasma gondii. The SERION ELISA classic Toxoplasma gondii IgG and IgM test allows for the determination of the immune status and the detection of the antibodies synthesized in the body to diagnose encephalitis and, by using the corresponding avidin test, to determine the avidity of the IgG antibodies to differentiate between acute infection and previous infections. The SERION ELISA classic Toxoplasma gondii IgM test serves as an initial test to detect acute infections

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for Quantitative/Qualitative Test Kit for IgM Antibodies Against Toxoplasma gondii 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 2402927ĐKLH/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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