BD MAX Vaginal Panel, BD MAX Instrument

DEN160001 is the FDA 510(k) clearance record for BD MAX Vaginal Panel, BD MAX Instrument, a class II device, cleared for Geneohm Sciences Canada, Inc. (Bd Diagnostics) on 2016-10-28 under FDA product code PQA (Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System). FDA's definition for product code PQA reads: "A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The...". FDA records list 4 510(k) clearances for Geneohm Sciences Canada, Inc. (Bd Diagnostics), from 2013-04-02 to 2019-10-21. As of 2026-09-10, FDA records show no recalls naming DEN160001.