FDA device listing
GeneXpert DX System; GeneXpert Xpress System; GeneXpert System (G3); GeneXpert G3 Module
FDA device listing 1768162015 · Sanmina Corporation
Key facts
| Proprietary names | GeneXpert DX System; GeneXpert Xpress System; GeneXpert System (G3); GeneXpert G3 Module |
|---|---|
| Owner/operator | Sanmina Corporation |
| Owner/operator number | 2129538 |
| Product codes | OOI |
| Device names | OOI - Real Time Nucleic Acid Amplification System |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570 |
| Review panels | Clinical Chemistry |
| Registered establishments | Sanmina, Sanmina-SCI Systems (Malaysia) Sdn Bhd |
| Establishment registrations | 3007867838, 3007923088 |
| FEI numbers | 1000161215, 3007923088 |
| Establishment operations | Contract Manufacturer |
| 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