PMA P160037S024

Device: BD Onclarity HPV Assay
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S024
Product code: MAQ
Decision date: 2026-04-02
Classification: Microbiology
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: Approval for expanding settings under which self-collected vaginal (SV) specimens are collected and for adding a workflow for SV specimen processing and testing.

Current openFDA PMA Record#

Device: BD Onclarity HPV Assay
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S024
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2026-04-02
Decision code: APPR
Date received: 2025-07-31
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for expanding settings under which self-collected vaginal (SV) specimens are collected and for adding a workflow for SV specimen processing and testing.