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Qualitative Antibody Test for Rubella Virus IgM - Vietnam Registration 2400195ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Qualitative Antibody Test for Rubella Virus IgM 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 2400195ĐKLH/BYT-HTTB and manufactured by DIA.PRO Diagnostic BioProbes S.r.l.. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA.

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2400195ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2400195ĐKLH/BYT-HTTB
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Device Details

Qualitative Antibody Test for Rubella Virus IgM
VN: Bộ xét nghiệm định tính kháng thể IgM kháng vi rút Rubella
Risk Class TTBYT Loại C

Registration Details

2400195ĐKLH/BYT-HTTB

17003715/ĐKLH-BYT-TB-CT

RUB IgM

Company Information

DIA.PRO Diagnostic BioProbes S.r.l.

Technical Details

Enzyme-linked immunosorbent assay (ELISA) to determine the presence of IgM antibodies against the Rubella virus in the blood and serum of individuals with the "Capture" system. This protocol is intended for monitoring patients with Rubella and for assessing the risk of congenital malformations due to Rubella infection during pregnancy.

Dates and Status

Feb 04, 2024