FDA device listing
Cepheid
FDA device listing 2057854279 · 823404997
Key facts
| Proprietary names | Cepheid |
|---|---|
| Owner/operator | 823404997 |
| Owner/operator number | 10094588 |
| Product codes | QOF |
| Device names | QOF - Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3981 |
| Review panels | Microbiology |
| Registered establishments | Springboard Manufacturing |
| Establishment registrations | 3021140368 |
| FEI numbers | 3021140368 |
| 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