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Qualitative test for detecting the flu A and flu B antigens - Vietnam Registration 2403189ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Qualitative test for detecting the flu A and flu B antigens in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2403189ĐKLH/BYT-HTTB and manufactured by Zhejiang Orient Gene Biotech Co.,Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.

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2403189ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403189ĐKLH/BYT-HTTB
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Device Details

Qualitative test for detecting the flu A and flu B antigens
VN: Que thử xét nghiệm định tính kháng nguyên cúm A và cúm B
Risk Class TTBYT Loại C

Registration Details

2403189ĐKLH/BYT-HTTB

000.00.04.G18-240802-0006

Influenza A & B Ag Rapid Test Strip (Swab)

GCFLU(A/B)-501a

Company Information

Zhejiang Orient Gene Biotech Co., Ltd.

Technical Details

Influenza A & B Ag Rapid Test Strip (Swab) is an in vitro immunoassay for qualitative detection of the influenza A nucleoprotein antigen (including the H1N1 subgroup) and B in nasal, throat, and nasal wash/aspirate fluids. The test aims to assist in the rapid diagnosis of influenza A and B virus infections.

Dates and Status

Nov 02, 2024