Quantitative DNA test for Lactobacillus spp., Gardnerella vaginalis, Atopobium vaginae and qualitative DNA test for Mobiluncus spp., Candida albicans, other Candida species; Trichomonas vaginalis
- Analysis ID
- 2301632ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-211104-0034
- Product Type
- Allplex™ Vaginitis Screening Assay
- Product Code
- SD9750Y
- Manufacturer
- Seegene, Inc.
- Manufacturer Country
- REPUBLIC OF
- 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).
- Registration Date
- Nov 22, 2023
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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