Qualitative HBeAg /Anti- HBe Test Kit - Vietnam Registration 2400196ĐKLH/BYT-HTTB
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.
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Device Details
Registration Details
2400196ĐKLH/BYT-HTTB
000.00.04.G18-220629-0005
VIDAS® HBe/Anti-HBe
30305
Technical Details
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
Feb 04, 2024