FDA device listing
BioFire Respiratory Panel 2.1,BioFire RP2.1
FDA device listing 1280671507 · BIOMERIEUX SA
Key facts
| Proprietary names | BioFire Respiratory Panel 2.1,BioFire RP2.1 |
|---|---|
| Owner/operator | BIOMERIEUX SA |
| Owner/operator number | 8020790 |
| Premarket submissions | DEN200031 |
| 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 | BioFire Diagnostics, LLC |
| Establishment registrations | 3002773840 |
| FEI numbers | 3002773840 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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