CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
March 16, 2023—BD announced it has received FDA 510(k) clearance for its BD Vaginal Panel on the BD Cor system.
The BD Vaginal Panel is the first microbiome-based PCR assay that uses a single swab and test to simultaneously detect organisms associated with bacterial vaginosis, vulvovaginal candidiasis, and Trichomonas vaginalis and reports a positive or negative result for each condition separately. If a test is positive for vulvovaginal candidiasis, the panel provides separate results for C. glabrata and C. krusei.
The 510(k) clearance for this panel on the BD Cor is the first high-throughput version of the test.