Drug test, reference standard for quantitative antibody IgG against HEV - Vietnam Registration 2403539ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Drug test, reference standard for quantitative antibody IgG against HEV 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 2403539ĐKLH/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
2403539ĐKLH/BYT-HTTB
000.00.04.G18-231218-0028
Elecsys Anti-HEV IgG
09044647190
Technical Details
The immunoassay test is used to quantitatively determine the presence of IgG antibodies against the hepatitis E virus (HEV) in human serum and plasma. The Elecsys Anti-HEV IgG test is used to support the detection of recent or past HEV infection. The electrochemiluminescence immunoassay (ECLIA) is used in the cobas e immunoassay system.
Dates and Status
Nov 14, 2024