FDA device listing
BIOFIRE FILMARRAY Pneumonia Panel,BIOFIRE FILMARRAY Pneumonia Panel plus,BIOFIRE Pneumonia Panel,BIOFIRE Pneumonia Panel…
FDA device listing 2023902544 · BIOMERIEUX SA
Key facts
| Proprietary names | BIOFIRE FILMARRAY Pneumonia Panel,BIOFIRE FILMARRAY Pneumonia Panel plus,BIOFIRE Pneumonia Panel,BIOFIRE Pneumonia Panel plus |
|---|---|
| Owner/operator | BIOMERIEUX SA |
| Owner/operator number | 8020790 |
| Premarket submissions | K243222 |
| Product codes | QDP, QDS |
| Device names | QDP - Respiratory Panel, QDS - Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3985, 866.4001 |
| Review panels | Microbiology, Pathology |
| 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