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# FDA Clears BD Vaginitis Test
- URL: https://www.fdaweb.com/fda-clears-bd-vaginitis-test/
- Published: 2023-03-16T12:00:00.000Z
- Updated: 2026-09-14T18:19:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153998

FDA has granted 510(k) clearance for the BD Vaginal Panel on the BD COR system, a comprehensive diagnostic test that is said to directly detect the three most common infectious causes of vaginitis using BD’s high-throughput molecular diagnostic platform for large laboratories. A company [statement](https://news.bd.com/2023-03-16-BD-Receives-FDA-510-k-Clearance-for-First-of-Its-Kind-High-Throughput-Diagnostic-Test-for-Infectious-Vaginitis?ref=fdaweb.com) says the Vaginal Panel is the first microbiome-based polymerase chain reaction assay that uses a single swab and test to simultaneously detect organisms associated with *bacterial vaginosis*, *vulvovaginal candidiasis*, and *trichomonas vaginalis* and reports a clear positive or negative result for each condition separately.

The company says the BD Vaginal Panel is the third assay available for use on the BD COR system in the U.S.