FDA device listing
Xpert MTB/RIF,Xpert MTB/RIF Ultra,Xpert MTB/XDR
FDA device listing 1133634053 · CEPHEID
Key facts
| Proprietary names | Xpert MTB/RIF,Xpert MTB/RIF Ultra,Xpert MTB/XDR |
|---|---|
| Owner/operator | CEPHEID |
| Owner/operator number | 9062742 |
| Product codes | PEU |
| Device names | PEU - System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3373 |
| Review panels | Microbiology |
| Registered establishments | Cepheid, CEPHEID |
| Establishment registrations | 3004530258, 3016838963 |
| FEI numbers | 3004530258, 3016838963 |
| 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