Vietnam MOH registration 2400875ĐKLH/BYT-HTTB

Anti-HEV IgG Quantitative Test Kit

VN: Bộ xét nghiệm định lượng Anti-HEV IgG

Vietnam·Risk Class TTBYT Loại C·VIDAS® Anti-HEV IgG·BIOMERIEUX SA·Registered Jun 24, 2024

Registration details

Analysis ID: 2400875ĐKLH/BYT-HTTB
Submission ID: 18006556/ĐKLH-BYT-TB-CT
Product Type: VIDAS® Anti-HEV IgG
Product Code: 418116

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-HEV IgG (HEVG) is an automated quantitative test performed on VIDAS machines to detect IgG antibodies against the hepatitis E virus in human serum or plasma, using the ELFA (Enzyme-Linked Fluorescence Assay) technique. VIDAS® Anti-HEV IgG is used as an adjunct to the VIDAS® Anti-HEV IgM test to aid in the diagnosis of hepatitis E in patients with symptoms and/or clinical signs of hepatitis.

Dates and status

Registration Date: Jun 24, 2024

About this record

Access comprehensive regulatory information for Anti-HEV IgG Quantitative Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400875ĐKLH/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.