Panels › Microbiology › Product code QSN · Class 2
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Regulation 866.3988
0510(k)s in 12 months (1 all time)
2recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in QSN
| Company | 510(k)s | Recalls |
|---|---|---|
| Biofire Diagnostics, LLC | 1 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2022 | DEN200066 | BioFire Joint Infection (JI) Panel Biofire Diagnostics, LLC | QSN |
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