HEV IgM Antibody Qualitative Test Control Reagent - Vietnam Registration 2403384ĐKLH/BYT-HTTB
Access comprehensive regulatory information for HEV IgM Antibody Qualitative Test Control Reagent 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 2403384ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403384ĐKLH/BYT-HTTB
000.00.04.G18-231218-0029
Elecsys Anti-HEV IgM
09056254190
Technical Details
The immunoassay test is used to qualitatively determine IgM antibodies against the hepatitis E virus (HEV) in human serum and plasma. The Elecsys Anti-HEV IgM test is used to support the detection of acute or recent HEV infection. The electrochemiluminescence immunoassay (ECLIA) is used for the cobas e immunoassay analyzer.
Dates and Status
Nov 06, 2024