Qualitative Antibody IgM to Cytomegalo Virus Test Kit - Vietnam Registration 2402539ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2402539ĐKLH/BYT-HTTB
17000554/ĐKLH-BYT-TB-CT
CMV IgM
CMVM.CE
Technical Details
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
Aug 30, 2024