FDA device listing
Panther Fusion Extraction Reagent-B,Panther Fusion GI Bacterial Assay,Panther Fusion GI Bacterial Assay Cartridge 96…
FDA device listing 1775029324 · HOLOGIC, INC.
Key facts
| Proprietary names | Panther Fusion Extraction Reagent-B,Panther Fusion GI Bacterial Assay,Panther Fusion GI Bacterial Assay Cartridge 96 Tests,Panther Fusion GI Bacterial Assay Controls,Panther Fusion Internal Control-B |
|---|---|
| Owner/operator | HOLOGIC, INC. |
| Owner/operator number | 9007676 |
| Premarket submissions | K251868 |
| Product codes | OOI, PCH |
| Device names | OOI - Real Time Nucleic Acid Amplification System, PCH - Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570, 866.3990 |
| Review panels | Clinical Chemistry, Microbiology |
| Registered establishments | Hologic, Inc. |
| Establishment registrations | 2024800 |
| FEI numbers | 2024800 |
| Establishment operations | Manufacturer |
| 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