Vietnam MOH registration 2403202ĐKLH/BYT-HTTB

Qualitative Test for Dengue Virus NS1 Antigen

VN: Khay thử xét nghiệm định tính kháng nguyên NS1 vi rút Dengue

Vietnam·Risk Class TTBYT Loại C·GenBody Dengue NS1 Ag·GenBody Inc.·Registered Nov 02, 2024

Registration details

Analysis ID: 2403202ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230821-0008
Product Type: GenBody Dengue NS1 Ag
Product Code: DVAG010

Company information

Manufacturer: GenBody Inc.
Manufacturer Country: REPUBLIC OF
Product Owner: GenBody Inc.
Authorized Representative: CÔNG TY TNHH ĐẦU TƯ THIẾT BỊ CÔNG NGHỆ NTN GLOBAL

Technical details

Intended Use: GenBody Dengue NS1 Ag is a rapid qualitative test for the detection of the NS1 antigen of the dengue virus in clinical samples. This test is intended for professional use and is suitable for initial screening. Positive samples must be confirmed by additional testing, such as nucleic acid testing and other immunological tests.

Dates and status

Registration Date: Nov 02, 2024

About this record

Access comprehensive regulatory information for Qualitative Test for Dengue Virus NS1 Antigen 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 2403202ĐKLH/BYT-HTTB and manufactured by GenBody Inc.. The authorized representative in Vietnam is CÔNG TY TNHH ĐẦU TƯ THIẾT BỊ CÔNG NGHỆ NTN GLOBAL.

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