PMA P160037S006
- Device
- BD Onclarity HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S006
- Product code
- MAQ
- Decision date
- 2020-03-19
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Change in materials used in manufacture of critical assay component.
Current openFDA PMA Record#
- Device
- BD Onclarity HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S006
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2020-03-19
- Decision code
- OK30
- Date received
- 2020-02-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in materials used in manufacture of critical assay component.