Drug test, reference standard for qualitative antibody IgM against cytomegalovirus (CMV) - Vietnam Registration 2403395ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Drug test, reference standard for qualitative antibody IgM against cytomegalovirus (CMV) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403395ĐKLH/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
2403395ĐKLH/BYT-HTTB
17001587/ĐKLH-BYT-TB-CT
Elecsys CMV IgM
07027133190
Technical Details
In vitro immunoassay for the qualitative determination of IgM antibodies against cytomegalovirus in human serum and plasma. The results obtained with the in vitro immunoassay used as a diagnostic tool for the detection of new CMV infections. The electrochemiluminescence immunoassay “ECLIA” (electrochemiluminescence immunoassay “ECLIA”) is used in base immunodiagnostic analyzers.
Dates and Status
Nov 06, 2024