PMA supplement
BP190403 S001: Elecsys HIV Duo
FDA PMA supplement · Real Time Process · Roche Diagnostics Operations,
Key facts
| Original PMA | BP190403 |
|---|---|
| Supplement number | S001 |
| Supplement type | Real Time Process |
| Trade name | Elecsys HIV Duo |
| Generic name | Hiv detection test |
| Applicant | Roche Diagnostics Operations, |
| Product code | MZF |
| Received date | Nov 17, 2020 |
| Decision date | Jan 29, 2021 |
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: