PMA supplement
BP030025 S029: Uni-Gold Recombigen HIV-1
FDA PMA supplement · 30-Day Notice · Trinity Biotech
Key facts
| Original PMA | BP030025 |
|---|---|
| Supplement number | S029 |
| Supplement type | 30-Day Notice |
| Trade name | Uni-Gold Recombigen HIV-1 |
| Generic name | Hiv detection test |
| Applicant | Trinity Biotech |
| Product code | MZF |
| Received date | Nov 21, 2018 |
| Decision date | Dec 20, 2018 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: