Qualitative Test for IgM Antibody Against Hepatitis A Virus - Vietnam Registration 240002051/PCBB-HN
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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Device Details
Registration Details
240002051/PCBB-HN
000.00.19.H26-240813-0009
HAV IgM CLIA Microparticles
CMC0702
Technical Details
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
Aug 14, 2024