PMA
BP050030: ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents
FDA PMA · Hiv detection test · Siemens Healthcare Diagnostics
Key facts
| PMA number | BP050030 |
|---|---|
| Trade name | ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents |
| Generic name | Hiv detection test |
| Applicant | Siemens Healthcare Diagnostics |
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Product code | MZF |
| Approval date | May 18, 2006 |
| Establishment registration | 2432235 |
| FEI number | 2432235 |
At a glance
- 10–99 Supplements
- Apr 18, 2022 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- No Withdrawn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: