Vietnam MOH registration 2400195ĐKLH/BYT-HTTB

Qualitative Antibody Test for Rubella Virus IgM

VN: Bộ xét nghiệm định tính kháng thể IgM kháng vi rút Rubella

Vietnam·Risk Class TTBYT Loại C·RUB IgM·DIA.PRO Diagnostic BioProbes S.r.l.·Registered Feb 04, 2024

Registration details

Analysis ID: 2400195ĐKLH/BYT-HTTB
Submission ID: 17003715/ĐKLH-BYT-TB-CT
Product Type: RUB IgM

Company information

Manufacturer: DIA.PRO Diagnostic BioProbes S.r.l.
Manufacturer Country: ITALY
Product Owner: DIA.PRO Diagnostic BioProbes S.r.l.
Authorized Representative: CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA

Technical details

Intended Use: 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

Registration Date: Feb 04, 2024

About this record

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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