FDA device listing
PD-L1 IHC 28-8 pharmDx
FDA device listing 1897445323 · Agilent Technologies, Inc
Key facts
| Proprietary names | PD-L1 IHC 28-8 pharmDx |
|---|---|
| Owner/operator | Agilent Technologies, Inc |
| Owner/operator number | 10038794 |
| Premarket submissions | P150025 |
| Product codes | PLS |
| Device names | PLS - Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.PLS |
| Review panels | Pathology |
| Registered establishments | Agilent Technologies Inc., Agilent Technologies, Inc, Agilent Technologies, Inc. |
| Establishment registrations | 2022180, 2916205, 3009189893 |
| FEI numbers | 2022180, 2916205, 3009189893 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database