IVD Department Qualitative HBeAg Testing - Vietnam Registration 2403388ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Qualitative HBeAg Testing 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 2403388ĐKLH/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 Theo phụ lục, Theo 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
2403388ĐKLH/BYT-HTTB
18008057/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
Elecsys HBeAg: An in vitro immunoassay for the qualitative determination of the e antigen of hepatitis B virus (HBeAg) in human serum and plasma. The ECLIA (Electrochemiluminescence Immunoassay) is used in the Elecsys and cobase immunoassay systems.; PreciControl HBeAg: PreciControlHBeAg is used to control the quality of the ElecsysHBeAg immunoassay on the cobase immunoassay analyzer.
Dates and Status
Nov 06, 2024