Drug test, qualitative antibody test for IgG and IgM against HBcAg - Vietnam Registration 2402950ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Drug test, qualitative antibody test for IgG and IgM against HBcAg 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 2402950ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Roche Diagnostics GmbH, and 1 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
2402950ĐKLH/BYT-HTTB
000.00.04.G18-230823-0015
Theo theo phụ lục
Theo phụ lục
Technical Details
In vitro immunoassay for the qualitative determination of IgG and IgM antibodies against the core antigen of the hepatitis B virus in human serum and plasma. The "ECLIA" (electrochemiluminescence immunoassay "ECLIA") is used for the cobas e immunoassay analyzers.
Dates and Status
Oct 22, 2024