FDA device listing
HercepTest for Automated Link Platforms
FDA device listing 1335552441 · Agilent Technologies, Inc
Key facts
| Proprietary names | HercepTest for Automated Link Platforms |
|---|---|
| Owner/operator | Agilent Technologies, Inc |
| Owner/operator number | 10038794 |
| Premarket submissions | P980018 |
| Product codes | MVC |
| Device names | MVC - System, Test, Her-2/Neu, Ihc |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.MVC |
| Review panels | Pathology |
| Registered establishments | Agilent Technologies Denmark ApS, Agilent Technologies Inc., Agilent Technologies Singapore (International) Pte Ltd., ATSI Logistics Center ApS |
| Establishment registrations | 9610099, 3003423869, 3009189893, 3013059683 |
| FEI numbers | 3002806778, 3003423869, 3009189893, 3013059683 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, 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