PMA P160037S010

Device: BD Onclarity™ HPV Assay
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S010
Product code: MAQ
Decision date: 2022-01-24
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement: Approval for the use of a new molecular sample tube closure cap in the BD Onclarity HPV Assay kits, when used on the BD Viper LT Instrument and BD COR System.

Current openFDA PMA Record#

Device: BD Onclarity™ HPV Assay
Applicant: Becton, Dickinson and Company
PMA number: P160037
Supplement: S010
Product code: MAQ
Generic name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date: 2022-01-24
Decision code: APPR
Date received: 2021-10-28
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the use of a new molecular sample tube closure cap in the BD Onclarity HPV Assay kits, when used on the BD Viper LT Instrument and BD COR System.