FDA device listing
MLH1 IHC pharmDx (Dako Omnis),MMR Negative Control Reagent, Mouse (Dako Omnis),MMR Negative Control Reagent, Rabbit…
FDA device listing 1331316884 · Agilent Technologies, Inc
Key facts
| Proprietary names | MLH1 IHC pharmDx (Dako Omnis),MMR Negative Control Reagent, Mouse (Dako Omnis),MMR Negative Control Reagent, Rabbit (Dako Omnis),MSH2 IHC pharmDx (Dako Omnis),MSH6 IHC pharmDx (Dako Omnis),PMS2 IHC pharmDx (Dako Omnis) |
|---|---|
| Owner/operator | Agilent Technologies, Inc |
| Owner/operator number | 10038794 |
| Premarket submissions | P250004 |
| Product codes | QNH |
| Device names | QNH - Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay |
| Device class | Class III |
| Classification regulations (21 CFR) | 864.1860 |
| Review panels | Hematology |
| 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