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# FDA Allows Marketing of Becton Dickinson Vaginitis Assay
- URL: https://www.fdaweb.com/fda-allows-marketing-of-becton-dickinson-vaginitis-assay/
- Published: 2016-10-31T12:00:00.000Z
- Updated: 2026-09-14T21:44:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137214

FDA has approved a *de novo* petition to allow marketing of a Becton Dickinson molecular test to detect the most common causes of vaginitis. The *in vitro* diagnostic is the first multiplex, real-time polymerase chain reaction assay that can detect microorganisms responsible for bacterial vaginosis, trichomoniasis and vulvovaginal candidiasis, according to the company. The BD MAX Vaginal Panel uses a “unique algorithm” to determine the ratio of healthy versus unhealthy bacteria, thus improving diagnosis, it says. It runs on the company’s BD MAX System, which “offers an efficient path to results by combining and automating amplification and detection into a single platform capable of running both FDA-cleared and open-system assays.