Anti-HEV IgG Quantitative Test Kit - Vietnam Registration 2400875ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Anti-HEV IgG Quantitative 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 2400875ĐKLH/BYT-HTTB and manufactured by BIOMERIEUX SA. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM.
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Device Details
Registration Details
2400875ĐKLH/BYT-HTTB
18006556/ĐKLH-BYT-TB-CT
VIDAS® Anti-HEV IgG
418116
Technical Details
VIDAS® Anti-HEV IgG (HEVG) is an automated quantitative test performed on VIDAS machines to detect IgG antibodies against the hepatitis E virus in human serum or plasma, using the ELFA (Enzyme-Linked Fluorescence Assay) technique. VIDAS® Anti-HEV IgG is used as an adjunct to the VIDAS® Anti-HEV IgM test to aid in the diagnosis of hepatitis E in patients with symptoms and/or clinical signs of hepatitis.
Dates and Status
Jun 24, 2024