Vietnam MOH registration 2400179ĐKLH/BYT-HTTB

Qualitative Test for IgM and IgG Antibodies against HSV-1

VN: Khay thử xét nghiệm định tính kháng thể IgM, IgG kháng HSV-1

Vietnam·Risk Class TTBYT Loại C·OnSite HSV-1 IgG/IgM Rapid Test·Beijing Genesee Biotech, Inc.·Registered Feb 04, 2024

Registration details

Analysis ID: 2400179ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220901-0004
Product Type: OnSite HSV-1 IgG/IgM Rapid Test
Product Code: R0203C

Company information

Manufacturer: Beijing Genesee Biotech, Inc.
Manufacturer Country: CHINA
Product Owner: CTK Biotech, Inc.
Authorized Representative: CÔNG TY TNHH AVANTA DIAGNOSTICS

Technical details

Intended Use: OnSite HSV-1 IgG/IgM Rapid Test is an immunoassay device, based on the principle of unidirectional flow, for qualitative detection and differentiation of antibodies (IgG and IgM) against herpes simplex virus type 1 (HSV-1) in serum, plasma, or whole blood of humans. It is intended to be used as a screening test by a qualified individual and to provide initial test results, which can support the diagnosis of HSV-1 infection. Any use or interpretation of the results from this preliminary test must be based on clinical manifestations and the professional diagnosis of a physician. Other testing methods must be used to confirm the results obtained from this test kit.

Dates and status

Registration Date: Feb 04, 2024

About this record

Access comprehensive regulatory information for Qualitative Test for IgM and IgG Antibodies against HSV-1 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 2400179ĐKLH/BYT-HTTB and manufactured by Beijing Genesee Biotech, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.

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