PMA
P160037: BD ONCLARITY HPV ASSAY
FDA PMA · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS · Becton, Dickinson and Company
Key facts
| PMA number | P160037 |
|---|---|
| Trade name | BD ONCLARITY HPV ASSAY |
| Generic name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Applicant | Becton, Dickinson and Company |
| Owner/operator | Becton Dickinson and Company |
| Product code | MAQ |
| Approval date | Feb 12, 2018 |
| Docket number | 18M-0736 |
| Notice date | Mar 1, 2018 |
| Establishment registration | 3008007472 |
| FEI number | 3008007472 |
At a glance
- 10–99 Supplements
- Aug 19, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: