PMA P160037S025
- Device
- BD Onclarity HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S025
- Product code
- MAQ
- Decision date
- 2026-04-02
- Classification
- Microbiology
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Approval to update labeling to reflect the findings of the Post-Approval Study P160037/S017/PAS001.
Current openFDA PMA Record#
- Device
- BD Onclarity HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S025
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2026-04-02
- Decision code
- APPR
- Date received
- 2025-10-08
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval to update labeling to reflect the findings of the Post-Approval Study P160037/S017/PAS001.