PMA P160037S020
- Device
- BD Onclarity™ HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S020
- Product code
- MAQ
- Decision date
- 2024-11-05
- Classification
- Microbiology
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Approval for changes to the BD Pre-warm Heater which is used with the BD Viper LT System to perform the BD Onclarity HPV Assay.
Current openFDA PMA Record#
- Device
- BD Onclarity™ HPV Assay
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S020
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2024-11-05
- Decision code
- APPR
- Date received
- 2024-05-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the BD Pre-warm Heater which is used with the BD Viper LT System to perform the BD Onclarity HPV Assay.