FDA device listing
Genexus™ Dx Barcodes 1-32 HD,Genexus™ Dx Bottle 1 and 3,Genexus™ Dx Bottle 2,Genexus™ Dx Cartridge,Genexus Dx Conical…
FDA device listing 1430565384 · Life Technologies Corporation
Key facts
| Proprietary names | Genexus™ Dx Barcodes 1-32 HD,Genexus™ Dx Bottle 1 and 3,Genexus™ Dx Bottle 2,Genexus™ Dx Cartridge,Genexus Dx Conical Bottles,Genexus Dx Filter,Genexus™ Dx GX5 Chip and Genexus Coupler,Genexus™ Dx Integrated Sequencer,Genexus™ Dx Pipette Tips,Genexus™ Dx Strip 1,Genexus™ Dx Strip 2-HD,Genexus™ Dx Strip 3-GX5,Genexus™ Dx Strip 4,Genexus™ Dx SW 6.8.2.0,Genexus™ Dx SW 6.8.2.1,Ion One Touch™ Dx,Ion… |
|---|---|
| Owner/operator | Life Technologies Corporation |
| Owner/operator number | 9915045 |
| Product codes | PFF |
| Device names | PFF - High Throughput Dna Sequence Analyzer |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2265 |
| Review panels | Immunology |
| Registered establishments | Life Technologies Corporation, LIFE TECHNOLOGIES CORPORATION, Life Technologies Holdings Pte Ltd. |
| Establishment registrations | 3003335080, 3003673482, 3007287152, 3009207631, 3011104381, 3015529000 |
| FEI numbers | 3003335080, 3003673482, 3007287152, 3009207631, 3011104381, 3015529000 |
| Establishment operations | Contract Manufacturer, 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