Vietnam MOH registration 2402539ĐKLH/BYT-HTTB

Qualitative Antibody IgM to Cytomegalo Virus Test Kit

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

Vietnam·Risk Class TTBYT Loại C·CMV IgM·DIA.PRO Diagnostic BioProbes S.r.l.·Registered Aug 30, 2024

Registration details

Analysis ID: 2402539ĐKLH/BYT-HTTB
Submission ID: 17000554/ĐKLH-BYT-TB-CT
Product Type: CMV IgM
Product Code: CMVM.CE

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) for the determination of IgM antibodies against the cytomegalovirus (CMV) in human serum and plasma with the "Capture" system. The test system is used for the diagnosis of CMV infection in patients and the control of the risk of congenital CMV infection in infants born to mothers infected with CMV during pregnancy. For in vitro diagnostic use only.

Dates and status

Registration Date: Aug 30, 2024

About this record

Access comprehensive regulatory information for Qualitative Antibody IgM to Cytomegalo Virus Test Kit 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 2402539ĐKLH/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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