Vietnam MOH registration 2301696ĐKLH/BYT-HTTB

Qualitative DNA Test for Herpes simplex virus type 1, Herpes simplex virus type 2, Haemophilus ducreyi, Cytomegalovirus, Lymphogranuloma venereum (Chlamydia trachomatis Serovar L), Treponema pallidum and Varicella-zoster virus

VN: Bộ xét nghiệm định tính ADN Herpes simplex virus type 1, Herpes simplex virus type 2, Haemophilus ducreyi, Cytomegalovirus , Lymphogranuloma venereum (Chlamydia trachomatis Serovar L), Treponema pallidum và Varicella-zoster virus
Vietnam flagVietnam·Risk Class TTBYT Loại C·Allplex™ Genital Ulcer Assay·Seegene, Inc.·Registered Dec 22, 2023
Registration details
Analysis ID
2301696ĐKLH/BYT-HTTB
Submission ID
19010829/ĐKLH-BYT-TB-CT
Product Type
Allplex™ Genital Ulcer Assay
Product Code
SD9802X
Company information
Manufacturer
Seegene, Inc.
Manufacturer Country
REPUBLIC OF
Technical details
Intended Use
Qualitative in vitro testing to detect either single or multiple pathogens: Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2), Haemophilus ducreyi (HD), Cytomegalovirus (CMV), Lymphogranuloma venereum (LGV, Chlamydia trachomatis Serovar L), Treponema pallidum (TP), and Varicella-zoster virus (VZV) from urine, genital exudate, and cell culture samples in liquid.
Dates and status
Registration Date
Dec 22, 2023
About this record

Access comprehensive regulatory information for Qualitative DNA Test for Herpes simplex virus type 1, Herpes simplex virus type 2, Haemophilus ducreyi, Cytomegalovirus, Lymphogranuloma venereum (Chlamydia trachomatis Serovar L), Treponema pallidum and Varicella-zoster virus 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 2301696ĐKLH/BYT-HTTB and manufactured by Seegene, Inc..

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