IVD Department Qualitative IgM Antibody Test for Rubella Virus - Vietnam Registration 2400636ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Qualitative IgM Antibody Test for Rubella Virus 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 2400636ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Beckman Coulter, Inc., Theo phụ lục, and 2 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
2400636ĐKLH/BYT-HTTB
000.00.04.G18-210323-0004
Theo theo phụ lục
Theo phụ lục
Technical Details
Elecsys Rubella IgM: An in vitro immunoassay for the qualitative determination of IgM antibodies against the Rubella virus in human serum and plasma. The ECLIA (Electrochemiluminescence Immunoassay) is used on Elecsys and cobas e immunoassay analyzers. PreciControl Rubella IgM: PreciControl Rubella IgM is used to control the quality of the Elecsys Rubella IgM immunoassay on the cobas e immunoassay analyzer.
Dates and Status
May 10, 2024