PMA
BP160050: Elecsys HIV combi PT
FDA PMA · Hiv detection test · Roche Diagnostics Operations,
Key facts
| PMA number | BP160050 |
|---|---|
| Trade name | Elecsys HIV combi PT |
| Generic name | Hiv detection test |
| Applicant | Roche Diagnostics Operations, |
| Owner/operator | Roche Diagnostics Operations Inc. |
| Product code | MZF |
| Approval date | Jun 21, 2017 |
| Establishment registration | 1823260 |
| FEI number | 1823260 |
At a glance
- 10–99 Supplements
- Nov 10, 2021 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- No Withdrawn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: