Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
Regulation 866.4001
0510(k)s in 12 months (3 all time)
1recalls in 12 months (6 all time)
4recalls that name a 510(k)
Top companies in QDS
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Diagnostics, LLC | 2 | 6 |
| Biofire Diagnostics, LLC (Biomerieux) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 2024 | K243222 | BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumon Biofire Diagnostics, LLC (Biomerieux) | QDS |
| Oct 27, 2022 | K222601 | FilmArray Pneumonia Panel plus Biofire Diagnostics, LLC | QDS |
| Nov 15, 2018 | K181324 | FilmArray Pneumonia Panel plus Biofire Diagnostics, LLC | QDS |
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