FDA device listing
ACIS III Tissue Micro-Array Application Software,ARK (Animal Research Kit)/HRP,Dako EyeShare Software - 25 License…
FDA device listing 1550794870 · Agilent Technologies, Inc
Key facts
| Proprietary names | ACIS III Tissue Micro-Array Application Software,ARK (Animal Research Kit)/HRP,Dako EyeShare Software - 25 License Pack,Dako EyeShare Software - 5 License Pack,Dako LSAB2 System-HRP for use on Rat Specimens,Epstein-Barr Virus (EBER) PNA Probe/Fluorescein,FluoroSpheres,Goat Serum (Normal),Isotype Reagent, Mouse IgG1/PB,Isotype Reagent, Mouse IgG1/PerCP,Monoclonal Mouse Anti-Bromodeoxyuridine, Clone… |
|---|---|
| Owner/operator | Agilent Technologies, Inc |
| Owner/operator number | 10038794 |
| Product codes | OTU |
| Device names | OTU - Research Use Only/Pathology |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.OTU |
| 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
- None listed 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