BD Onclarity HPV Assay
FDA premarket approval P160037/S023 · decided 2025-07-02
Approval details
- PMA number
- P160037
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BD Onclarity HPV Assay
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2025-04-10
- Decision date
- 2025-07-02
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Approval for modifications of the Thermocycler Reader (TCR) of the BD Viper LT System and BD COR PX/GX System on which the BD Onclarity HPV Assay is performed.
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