FDA device listing
Artisan Filter,Artisan Link,Artisan Link Pro,Autostainer Link 48,Autostainer Plus Link, Calibration Bottle…
FDA device listing 1608547904 · Agilent Technologies, Inc
Key facts
| Proprietary names | Artisan Filter,Artisan Link,Artisan Link Pro,Autostainer Link 48,Autostainer Plus Link, Calibration Bottle Kit,Autostainer Slide Racks, 4 Pack,Dako CoverStainer,Dako CoverStainer Dip Tank,Dako Coverstainer Slide Rack,Dako Distribution Plates, 10 pcs, CoverStainer,Dako Distribution Plates, 2 pcs, CoverStainer,Dako Omnis,Dako Omnis 110,Dako Omnis 165,Dako Omnis 165 Duo,Dako Omnis Buffer/Solvent… |
|---|---|
| Owner/operator | Agilent Technologies, Inc |
| Owner/operator number | 10038794 |
| Product codes | KPA |
| Device names | KPA - Slide Stainer, Automated |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.3800 |
| Review panels | Pathology |
| Registered establishments | Agilent Technologies Denmark ApS, Agilent Technologies Inc., Agilent Technologies, Inc, Agilent Technologies, Inc., Agilent Technologies LDA, Agilent Technologies Singapore (International) Pte Ltd., ATSI Logistics Center ApS |
| Establishment registrations | 2022180, 2916205, 9610099, 3003423869, 3005716001, 3009189893, 3013059683 |
| FEI numbers | 2022180, 2916205, 3002806778, 3003423869, 3005716001, 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