BD Onclarity HPV Assay
FDA premarket approval P160037/S006 · decided 2020-03-19
Approval details
- PMA number
- P160037
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BD Onclarity HPV Assay
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2020-02-21
- Decision date
- 2020-03-19
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Change in materials used in manufacture of critical assay component.
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