PMA P160037
- Device
- BD Onclarity™ HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S013
- Product code
- MAQ
- Decision date
- 2026-08-14
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Approval for the extension of self-collected vaginal specimen transport and storage conditions for the BD Onclarity HPV Assay.
Current openFDA PMA Record#
- Device
- BD Onclarity™ HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S028
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2026-08-14
- Decision code
- APPR
- Date received
- 2026-05-22
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the extension of self-collected vaginal specimen transport and storage conditions for the BD Onclarity HPV Assay.