PMA supplement
P150013 S028: PD-L1 IHC 22C3 pharmDx (Dako Omnis)
FDA PMA supplement · Normal 180 Day Track · Agilent Technologies, Inc.
Key facts
| Original PMA | P150013 |
|---|---|
| Supplement number | S028 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PD-L1 IHC 22C3 pharmDx (Dako Omnis) |
| Generic name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
| Applicant | Agilent Technologies, Inc. |
| Product code | PLS |
| Received date | Nov 22, 2024 |
| Decision date | Aug 4, 2025 |
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: