Vietnam MOH registration 2301123ĐKLH/BYT-HTTB

Qualitative DNA Testing of the Bacteria Causing Vaginal Inflammation

VN: Thuốc thử xét nghiệm định tính ADN của các vi sinh vật gây viêm âm đạo

Vietnam·Risk Class TTBYT Loại C·BD MAX™ Vaginal Panel·GeneOhm Sciences Canada ULC·Registered Oct 03, 2023

Registration details

Analysis ID: 2301123ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210727-0019
Product Type: BD MAX™ Vaginal Panel
Product Code: 443712

Company information

Manufacturer: GeneOhm Sciences Canada ULC
Manufacturer Country: CANADA

Technical details

Intended Use: BD MAX™ Vaginal Panel is performed on the BD MAX System and is an in vitro qualitative automated diagnostic test that directly detects the target DNA from bacteria associated with bacterial vaginosis (the qualitative results are reported based on the detection and quantification of the target biological markers), Candida species associated with Candida vaginitis and Trichomonas vaginalis from vaginal swabs of symptomatic patients with signs of bacterial vaginosis / vaginitis. The test uses real-time polymerase chain reaction (PCR) to amplify the specific target DNA and uses target-specific fluorescent probe samples to detect and differentiate DNA from: •Bacterial vaginosis-associated markers (not reporting individual markers) Lactobacillus spp. (L. crispatus and L. jebenii) Gardnerella vaginalis Atopobium vaginale Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) Megasphaera-1. •Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniebis) •Candida glabrata •Candida krusei •Trichomonas vaginalis BD MAX Vaginal Panel aims to support the diagnosis of vaginitis in women with clinical signs consistent with bacterial vaginosis, Candida vaginitis and trichomoniasis.

Dates and status

Registration Date: Oct 03, 2023

About this record

Access comprehensive regulatory information for Qualitative DNA Testing of the Bacteria Causing Vaginal Inflammation 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 2301123ĐKLH/BYT-HTTB and manufactured by GeneOhm Sciences Canada ULC.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.