Onclarity HPV Assay
FDA premarket approval P160037/S002 · decided 2019-05-13
Approval details
- PMA number
- P160037
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Onclarity HPV Assay
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2019-02-26
- Decision date
- 2019-05-13
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Approval for use of a modified SurePath vial for collection of specimens to be tested with the Onclarity HPV Assay, and the automated transfer of pre- and post- cytology aliquots using the BD Totalys Multiprocessor for testing with the BD Onclarity Assay.
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