BD Receives the US FDA’s Clearance for Infectious Vaginitis Test for Use in High Throughput Platform
- The US FDA has granted 510(k) clearance to the BD Vaginal Panel to detect multiple common types of vaginitis on the BD COR system, a high throughput analytical system using 1 swab, one test in large laboratories
- The BD COR system is the PCR assay that can detect organisms linked to bacterial vaginosis, vulvovaginal candidiasis (VVC), and Trichomonas vaginalis & provides accurate and reliable results. The BD Vaginal Panel is the third assay available for use on the BD COR System in the US
- A single test can help to reduce the need for additional testing, avoidable treatment use & risk of contracting STIs. The BD Vaginal Panel, the only US FDA-cleared NAAT that provides separate results for two Candida species
Ref: PRNewswire | Image: BD
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