BD Onclarity HPV Assay/BD COR System
FDA premarket approval P160037/S005 · decided 2021-08-24
Approval details
- PMA number
- P160037
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BD Onclarity HPV Assay/BD COR System
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2020-01-14
- Decision date
- 2021-08-24
- Days to decision
- 588 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Approval for use of the BD Onclarity HPV Assay on the BD COR (PX/GX) instrument system.
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