BD Onclarity HPV Assay, BD Viper LT System
FDA premarket approval P160037/S001 · decided 2019-03-26
Approval details
- PMA number
- P160037
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BD Onclarity HPV Assay, BD Viper LT System
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Becton, Dickinson and Company
- Date received
- 2018-04-27
- Decision date
- 2019-03-26
- Days to decision
- 333 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Sparks, MD
- Statement
- Approval for a change to plastic resin used for reagent storage containers.
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