Vietnam MOH registration 2301632ĐKLH/BYT-HTTB

Quantitative DNA test for Lactobacillus spp., Gardnerella vaginalis, Atopobium vaginae and qualitative DNA test for Mobiluncus spp., Candida albicans, other Candida species; Trichomonas vaginalis

VN: Bộ xét nghiệm định lượng ADN Lactobacillus spp., Gardnerella vaginalis, Atopobium vaginae và định tính ADN vi khuẩn Mobiluncus spp., Candida albicans, các nấm Candida khác; Trichomonas vaginalis
Vietnam flagVietnam·Risk Class TTBYT Loại C·Allplex™ Vaginitis Screening Assay·Seegene, Inc.·Registered Nov 22, 2023
Registration details
Analysis ID
2301632ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-211104-0034
Product Type
Allplex™ Vaginitis Screening Assay
Product Code
SD9750Y
Company information
Manufacturer
Seegene, Inc.
Manufacturer Country
REPUBLIC OF
Technical details
Intended Use
In vitro quantitative and qualitative testing to detect single or multiple pathogens Lactobacillus spp., Gardnerella vaginalis, Atopobium vaginae, Mobiluncus spp., Candida albicans, other Candida species, and Trichomonas vaginalis from the genital swab sample and the cell culture sample in liquid. - Quantitative detection of Lactobacillus spp. (Lacto), Gardnerella vaginalis (GV), and Atopobium vaginae (AV). - Qualitative detection of Mobiluncus spp. (Mob), Candida albicans (CA), other Candida species (CO), and Trichomonas vaginalis (TV).
Dates and status
Registration Date
Nov 22, 2023
About this record

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