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Quantitative DNA test for Lactobacillus spp., Gardnerella vaginalis, Atopobium vaginae and qualitative DNA test for Mobiluncus spp., Candida albicans, other Candida species; Trichomonas vaginalis - Vietnam Registration 2301632ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Quantitative DNA test for Lactobacillus spp., Gardnerella vaginalis, Atopobium vaginae and qualitative DNA test for Mobiluncus spp., Candida albicans, other Candida species; Trichomonas vaginalis 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 2301632ĐKLH/BYT-HTTB and manufactured by Seegene, Inc..

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2301632ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2301632ĐKLH/BYT-HTTB
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Device Details

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
Risk Class TTBYT Loại C

Registration Details

2301632ĐKLH/BYT-HTTB

000.00.04.G18-211104-0034

Allplex™ Vaginitis Screening Assay

SD9750Y

Company Information

REPUBLIC OF

Technical Details

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

Nov 22, 2023