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Qualitative Test for HBsAg Antigen - Vietnam Registration 2400610ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Qualitative Test for HBsAg Antigen 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 2400610ĐKLH/BYT-HTTB and manufactured by Beijing Genesee Biotech, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Medicon Co., Ltd., and 1 recent registrations in the same category. 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.

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2400610ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2400610ĐKLH/BYT-HTTB
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Device Details

Qualitative Test for HBsAg Antigen
VN: Khay thử xét nghiệm định tính kháng nguyên HBsAg
OnSite HBsAg Combo Rapid Test
Risk Class TTBYT Loại D

Registration Details

2400610ĐKLH/BYT-HTTB

000.00.04.G18-230523-0021

OnSite HBsAg Combo Rapid Test

R0042C

Company Information

CTK Biotech, Inc.

Technical Details

The test used to qualitatively detect the presence of the HBsAg antigen in the serum, plasma, or whole blood of humans, aiding in the diagnosis of hepatitis B virus (HBV) infection

Dates and Status

May 10, 2024

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