Vietnam MOH registration 240002051/PCBB-HN

Qualitative Test for IgM Antibody Against Hepatitis A Virus

VN: Thuốc thử xét nghiệm định tính kháng thể IgM kháng vi rút viêm gan A

Vietnam·Risk Class TTBYT Loại B·HAV IgM CLIA Microparticles·AUTOBIO DIAGNOSTICS CO., LTD.·Registered Aug 14, 2024

Registration details

Analysis ID: 240002051/PCBB-HN
Submission ID: 000.00.19.H26-240813-0009
Product Type: HAV IgM CLIA Microparticles
Product Code: CMC0702

Company information

Manufacturer: AUTOBIO DIAGNOSTICS CO., LTD.
Product Owner: Autobio Diagnostics Co., Ltd.
Authorized Representative: CÔNG TY TNHH Y TẾ MINH NHẬT

Technical details

Intended Use: This test is based on the CLIA Microparticles fluorescent bead immunoassay to detect the presence of HAV IgM (antibody IgM against hepatitis A virus) in human serum or plasma (EDTA, heparin, or sodium citrate).

Dates and status

Registration Date: Aug 14, 2024

About this record

Access comprehensive regulatory information for Qualitative Test for IgM Antibody Against Hepatitis A Virus in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240002051/PCBB-HN and manufactured by AUTOBIO DIAGNOSTICS CO., LTD.. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ MINH NHẬT.

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