Vietnam MOH registration 2403189ĐKLH/BYT-HTTB

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

Vietnam·Risk Class TTBYT Loại C·Influenza A & B Ag Rapid Test Strip (Swab)·Zhejiang Orient Gene Biotech Co.,Ltd.·Registered Nov 02, 2024

Registration details

Analysis ID: 2403189ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240802-0006
Product Type: Influenza A & B Ag Rapid Test Strip (Swab)
Product Code: GCFLU(A/B)-501a

Company information

Manufacturer: Zhejiang Orient Gene Biotech Co.,Ltd.
Manufacturer Country: CHINA
Product Owner: Zhejiang Orient Gene Biotech Co., Ltd.
Authorized Representative: CÔNG TY TNHH AVANTA DIAGNOSTICS

Technical details

Intended Use: 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

Registration Date: Nov 02, 2024

About this record

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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