PMA P160037S022

Device: BD ONCLARITY HPV ASSAY
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S022
Product code: MAQ
Decision date: 2025-08-25
Classification: Microbiology
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: Approval for a manufacturing site located at Becton, Dickinson and Company, at 7 Loveton Circle, Sparks, MD, 21152, USA, for the manufacturing of the BD COR PX instrument.

Current openFDA PMA Record#

Device: BD ONCLARITY HPV ASSAY
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S022
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2025-08-25
Decision code: APPR
Date received: 2025-02-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Becton, Dickinson and Company, at 7 Loveton Circle, Sparks, MD, 21152, USA, for the manufacturing of the BD COR PX instrument.