PMA
BP180279: VioOne HIV Profile Supplemental Assay
FDA PMA · Hiv detection test · Avioq, Inc.
Key facts
| PMA number | BP180279 |
|---|---|
| Trade name | VioOne HIV Profile Supplemental Assay |
| Generic name | Hiv detection test |
| Applicant | Avioq, Inc. |
| Product code | MZF |
| Approval date | Oct 19, 2020 |
| FEI number | 3008376326 |
At a glance
- None Supplements
- Oct 19, 2020 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: