IVD Department Qualitative Antibody to HBeAg Testing - Vietnam Registration 2403588ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department Qualitative Antibody to 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 2403588ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403588ĐKLH/BYT-HTTB
18008055/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
Elecsys Anti-HBe: An in vitro immunoassay for the qualitative determination of human antibodies against the hepatitis B virus e antigen (HBeAg) in human serum and plasma. The ECLIA (Electrochemiluminescence Immunoassay) is used in the Elecsys and cobas e immunoassay systems. PreciControl Anti-HBe: PreciControl Anti-HBe is used to control the quality of the Elecsys Anti-HBe immunoassay on the cobas e immunoassay system.
Dates and Status
Nov 14, 2024