PMA
BP000023: MedMira Rapid HIV Test
FDA PMA · Hiv detection test · MedMira Labs
Key facts
| PMA number | BP000023 |
|---|---|
| Trade name | MedMira Rapid HIV Test |
| Generic name | Hiv detection test |
| Applicant | MedMira Labs |
| Product code | MZF |
| Approval date | Apr 16, 2003 |
At a glance
- 10–99 Supplements
- Sep 28, 2017 Latest supplement decision
- No Withdrawn
- No 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: