Vietnam MOH registration 2400196ĐKLH/BYT-HTTB

Qualitative HBeAg /Anti- HBe Test Kit

VN: Bộ xét nghiệm định tính HBeAg /Anti- HBe

Vietnam·Risk Class TTBYT Loại D·VIDAS® HBe/Anti-HBe·BIOMERIEUX SA·Registered Feb 04, 2024

Registration details

Analysis ID: 2400196ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220629-0005
Product Type: VIDAS® HBe/Anti-HBe
Product Code: 30305

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 HBe/Anti-HBe is a qualitative test performed on the VIDAS machine, which detects the hepatitis B virus e antigen (HBe Ag) or antibody (anti-HBe) in human serum or plasma (coagulated with lithium heparin, sodium citrate, or EDTA) using the ELFA (Enzyme-Linked Fluorescence Assay) technique.

Dates and status

Registration Date: Feb 04, 2024

About this record

Access comprehensive regulatory information for Qualitative HBeAg /Anti- HBe 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 2400196ĐKLH/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.