Device Listing 2023902544
Listing Summary#
- Listing key
- 2023902544
- Premarket submission
- K243222
- Device
- BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
- Applicant
- Biofire Diagnostics, LLC (Biomerieux)
- Product code
- QDS
- Decision date
- 2024-11-06