PMA
BP090022: Avioq HIV-1 Microelisa System
FDA PMA · Hiv detection test · Avioq, Inc.
Key facts
| PMA number | BP090022 |
|---|---|
| Trade name | Avioq HIV-1 Microelisa System |
| Generic name | Hiv detection test |
| Applicant | Avioq, Inc. |
| Product code | MZF |
| Approval date | Sep 21, 2009 |
| FEI number | 3008376326 |
At a glance
- 1–9 Supplements
- Jun 8, 2016 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- No Withdrawn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: