PMA
BP030025: Uni-Gold Recombigen HIV-1
FDA PMA · Hiv detection test · Trinity Biotech
Key facts
| PMA number | BP030025 |
|---|---|
| Trade name | Uni-Gold Recombigen HIV-1 |
| Generic name | Hiv detection test |
| Applicant | Trinity Biotech |
| Owner/operator | TRINITY BIOTECH, PLC |
| Product code | MZF |
| Approval date | Dec 23, 2003 |
| Establishment registration | 9681576 |
| FEI number | 3002546385 |
At a glance
- 1–9 Supplements
- Dec 20, 2018 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- No Withdrawn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: