Vietnam MOH registration 2403588ĐKLH/BYT-HTTB

IVD Department Qualitative Antibody to HBeAg Testing

VN: Bộ IVD xét nghiệm định tính kháng thể kháng HBeAg

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Registered Nov 14, 2024

Registration details

Analysis ID: 2403588ĐKLH/BYT-HTTB
Submission ID: 18008055/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Nov 14, 2024

About this record

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.

This page provides complete technical specifications, regulatory compliance details. 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.