Panels › Microbiology › Product code QMV · Class 2
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Regulation 866.3966
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QMV
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Defense, LLC | 2 | 0 |
| Biofire Diagnostics, LLC (Biomerieux) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2024 | K243463 | BIOFIRE FILMARRAY Tropical Fever Panel Biofire Diagnostics, LLC (Biomerieux) | QMV |
| Oct 20, 2022 | K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel Biofire Defense, LLC | QMV |
| Nov 20, 2020 | DEN200043 | FilmArray Global Fever Panel Biofire Defense, LLC | QMV |
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