PMA P160037S001
- Device
- BD Onclarity HPV Assay, BD Viper LT System
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S001
- Product code
- MAQ
- Decision date
- 2019-03-26
- Classification
- Kit, Dna Detection, Human Papillomavirus
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Approval order statement
- Approval for a change to plastic resin used for reagent storage containers.
Current openFDA PMA Record#
- Device
- BD Onclarity HPV Assay, BD Viper LT System
- Applicant
- Becton, Dickinson and Company
- PMA number
- P160037
- Supplement
- S001
- Product code
- MAQ
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Decision date
- 2019-03-26
- Decision code
- APPR
- Date received
- 2018-04-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to plastic resin used for reagent storage containers.