Panels › Microbiology › Product code QBH · Class 2
Lower Respiratory Microbial Nucleic Acid Detection System
Regulation 866.3985
0510(k)s in 12 months (2 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in QBH
| Company | 510(k)s | Recalls |
|---|---|---|
| BioFire Diagnostics, LLC | 0 | 4 |
| Curetis GmbH | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 20, 2019 | K191967 | Unyvero LRT BAL Application Curetis GmbH, DE | QBH |
| Apr 3, 2018 | DEN170047 | Curetis Unyvero LRT Application Curetis GmbH, DE | QBH |
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