Vietnam MOH registration 2400876ĐKLH/BYT-HTTB

Anti-HBs Quantitative Test Kit

VN: Bộ xét nghiệm định lượng Anti-HBs

Vietnam·Risk Class TTBYT Loại D·VIDAS® Anti-HBs Total II·BIOMERIEUX SA·Registered Jun 24, 2024

Registration details

Analysis ID: 2400876ĐKLH/BYT-HTTB
Submission ID: 17004300/ĐKLH-BYT-TB-CT
Product Type: VIDAS® Anti-HBs Total II
Product Code: 30318

Company information

Manufacturer: BIOMERIEUX SA
Manufacturer Country: FRANCE
Product Owner: BIOMERIEUX SA
Authorized Representative: CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM

Technical details

Intended Use: VIDAS® Anti-HBs Total II is an automated quantitative assay for use on the VIDAS® range of devices, based on the enzyme-linked immunosorbent assay (ELISA) principle, to detect antibodies against the hepatitis B surface antigen (Anti-HBs) in human serum or plasma by the ELFA (Enzyme-Linked Fluorescence Assay) technique.

Dates and status

Registration Date: Jun 24, 2024

About this record

Access comprehensive regulatory information for Anti-HBs Quantitative Test Kit 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 2400876ĐKLH/BYT-HTTB and manufactured by BIOMERIEUX SA. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX 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.