FDA device listing
Ion Torrent™ Genexus™ Dx Barcodes 1-32 HD,Ion Torrent™ Genexus™ Dx Conical Bottles,Ion Torrent™ Genexus™ Dx Filter,Ion…
FDA device listing 1484503019 · Life Technologies Corporation
Key facts
| Proprietary names | Ion Torrent™ Genexus™ Dx Barcodes 1-32 HD,Ion Torrent™ Genexus™ Dx Conical Bottles,Ion Torrent™ Genexus™ Dx Filter,Ion Torrent™ Genexus™ Dx GX5™ Chip and Genexus™ Coupler,Ion Torrent™ Genexus™ Dx Integrated Sequencer,Ion Torrent™ Genexus™ Dx Library Strips 1 and 2-HD,Ion Torrent™ Genexus™ Dx Pipette Tips,Ion Torrent™ Genexus™ Dx Sequencing Kit,Ion Torrent™ Genexus™ Dx SW, Installer V6.6,Ion… |
|---|---|
| Owner/operator | Life Technologies Corporation |
| Owner/operator number | 9915045 |
| Product codes | PZM |
| Device names | PZM - Next Generation Sequencing Based Tumor Profiling Test |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.6080 |
| Review panels | Pathology |
| Registered establishments | Life Technologies Corporation |
| Establishment registrations | 3003335080 |
| FEI numbers | 3003335080 |
| Establishment operations | U.S. Manufacturer of Export Only Devices |
| 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