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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2024 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit) Open, Classified |
QBH | K180966 |
| Aug 21, 2023 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only Open, Classified |
QBH | K180966 K212727 |
| Jun 7, 2021 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Pneumo)
Part Numbers:
Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit)
Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit) Terminated |
QBH | K180966 |
| Apr 16, 2021 | BioFire Diagnostics, LLC FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 Terminated |
QBH | K180966 |
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