PMA
BP050051: VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator; VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack
FDA PMA · Hiv detection test · Ortho-Clinical Diagnostics, In
Key facts
| PMA number | BP050051 |
|---|---|
| Trade name | VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator; VITROS Immunodiagnostics Products Anti-HIV 1+2 Reagent Pack |
| Generic name | Hiv detection test |
| Applicant | Ortho-Clinical Diagnostics, In |
| Owner/operator | QuidelOrtho Corporation |
| Product code | MZF |
| Approval date | Mar 27, 2008 |
| Establishment registration | 2024674 |
| FEI number | 2024674 |
At a glance
- 10–99 Supplements
- Jun 19, 2019 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- No Withdrawn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: