PMA P160037S013
- Device
- BD Onclarity HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S013
- Product code
- MAQ
- Decision date
- 2022-12-07
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Add an alternative supplier of a critical component.
Current openFDA PMA Record#
- Device
- BD Onclarity HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S013
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2022-12-07
- Decision code
- OK30
- Date received
- 2022-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternative supplier of a critical component.