PMA P160037S023

Device: BD Onclarity HPV Assay
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S023
Product code: MAQ
Decision date: 2025-07-02
Classification: Microbiology
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: Approval for modifications of the Thermocycler Reader (TCR) of the BD Viper LT System and BD COR PX/GX System on which the BD Onclarity HPV Assay is performed.

Current openFDA PMA Record#

Device: BD Onclarity HPV Assay
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S023
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2025-07-02
Decision code: APPR
Date received: 2025-04-10
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for modifications of the Thermocycler Reader (TCR) of the BD Viper LT System and BD COR PX/GX System on which the BD Onclarity HPV Assay is performed.