PMA P160037S026
- Device
- BD FOX™ PCR Extraction Tubes; BD Onclarity™ HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S026
- Product code
- MAQ
- Decision date
- 2026-02-12
- Classification
- Microbiology
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- an internal building to building transfer of a manufacturing process
Current openFDA PMA Record#
- Device
- BD FOX™ PCR Extraction Tubes; BD Onclarity™ HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S026
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2026-02-12
- Decision code
- OK30
- Date received
- 2026-01-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an internal building to building transfer of a manufacturing process