BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit

K201017 is the FDA 510(k) clearance record for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit, a class II device, cleared for Geneohm Sciences Canada, Inc. (Bd Life Sciences) on 2021-10-18 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 one 510(k) clearance for Geneohm Sciences Canada, Inc. (Bd Life Sciences). As of 2026-09-10, FDA records show no recalls naming K201017.