BD Onclarity HPV Assay
FDA premarket approval P160037/S019 · decided 2024-04-18
Approval details
- PMA number
- P160037
- Supplement
- S019
- 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
- 2024-01-31
- Decision date
- 2024-04-18
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Approval for software modifications to the BD Onclarity HPV Assay to allow laboratorians/laboratory sites the ability to access Ct values for internal assay controls and positive clinical samples.
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