PMA P160037S027
- Device
- BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR™ HPV Extraction Trough (SKU 444074)
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S027
- Product code
- MAQ
- Decision date
- 2026-08-19
- Classification
- Microbiology
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Requested a site change for P160037/S027
Current openFDA PMA Record#
- Device
- BD Onclarity HPV Assay Reagent Pack (SKU 444075) and BD COR™ HPV Extraction Trough (SKU 444074)
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S027
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2026-08-19
- Decision code
- APPR
- Date received
- 2026-02-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Requested a site change for P160037/S027