PMA supplement
P090008 S023: vitros hbeag assays
FDA PMA supplement · real-time process · ROCHE DIAGNOSTICS CORP.
Key facts
| Original PMA | P090008 |
|---|---|
| Supplement number | S023 |
| Supplement type | real-time process |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | vitros hbeag assays |
| Generic name | Assay, enzyme linked immunosorbent, hepatitis c virus |
| Applicant | ROCHE DIAGNOSTICS CORP. |
| Product code | MZO |
| Received date | Sep 30, 2022 |
| Decision date | Jan 24, 2023 |
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: