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Quantitative/Qualitative Test Kit for IgM Antibodies Against Toxoplasma gondii - Vietnam Registration 2402927ĐKLH/BYT-HTTB

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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2402927ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2402927ĐKLH/BYT-HTTB
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Device Details

Quantitative/Qualitative Test Kit for IgM Antibodies Against Toxoplasma gondii
VN: Bộ xét nghiệm định lượng/định tính kháng thể IgM kháng Toxoplasma gondii
Risk Class TTBYT Loại C

Registration Details

2402927ĐKLH/BYT-HTTB

000.00.04.G18-220504-0104

SERION ELISA classic Toxoplasma gondii IgM

ESR110M

Company Information

GERMANY

Institut Virion/Serion GmbH

Technical Details

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

Oct 22, 2024