FDA device listing
ADVANCE HRP,AEC+ High Sensitivity Substrate Chromogen, Ready-to-Use,AEC Substrate-Chromogen, Ready-to-Use,AEC+…
FDA device listing 1859284327 · Agilent Technologies, Inc
Key facts
| Proprietary names | ADVANCE HRP,AEC+ High Sensitivity Substrate Chromogen, Ready-to-Use,AEC Substrate-Chromogen, Ready-to-Use,AEC+ Substrate-Chromogen, Ready-to-Use,Antibody Diluent,Anti-FITC-AP CISH Accessory Kit,Artisan Clearing Solution,Artisan Maintenance Kit,Artisan Wash Solution (50x),BCIP/NBT Substrate System,Biotin Blocking System,Chemiluminescent System for Nucleic Acid Blotting,Clear-It Cleaning Reagent for… |
|---|---|
| Owner/operator | Agilent Technologies, Inc |
| Owner/operator number | 10038794 |
| Product codes | PPM |
| Device names | PPM - General Purpose Reagent |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| Registered establishments | Agilent Technologies Denmark ApS, Agilent Technologies Inc., Agilent Technologies, Inc, Agilent Technologies, Inc., Agilent Technologies Singapore (International) Pte Ltd., ATSI Logistics Center ApS |
| Establishment registrations | 2022180, 2916205, 9610099, 3003423869, 3009189893, 3013059683 |
| FEI numbers | 2022180, 2916205, 3002806778, 3003423869, 3009189893, 3013059683 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract Manufacturer, Repackager/Relabeler, Foreign Exporter, 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