| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04260364750058 | LRT BAL Cartridge Kit | 10091 | Kit of 12 disposable Unyvero LRT BAL Cartridges, including sample tubes, sample Kit of 12 disposable Unyvero LRT BAL Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit) | QBH | Lower respiratory microbial nucleic acid detection system | 2 | Unyvero |
| 2 | 04260364750041 | M1 Master Mix Tube Kit | 10020 | Kit of 12 Unyvero M1 Master Mix Tubes, to be used with Unyvero LRT Cartridges | QBH | Lower respiratory microbial nucleic acid detection system | 2 | Unyvero |
| 3 | 04260364750034 | LRT Cartridge Kit | 10049 | Kit of 12 disposable Unyvero LRT Cartridges, including sample tubes, sample tube Kit of 12 disposable Unyvero LRT Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit) | QBH | Lower respiratory microbial nucleic acid detection system | 2 | Unyvero |
| 4 | 04260364750010 | L4 Lysator | 60002 | Instrument to pre-process up to 4 samples for Unyvero Cartridges | QBH | Lower respiratory microbial nucleic acid detection system | 2 | Unyvero |
| 5 | 04260364750003 | A50 Analyzer | 60001 | Instrument to process 2 Unyvero Cartridges | QBH | Lower respiratory microbial nucleic acid detection system | 2 | Unyvero |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 04260364750058 | LRT BAL Cartridge Kit | 10091 | Kit of 12 disposable Unyvero LRT BAL Cartridges, including sample tubes, sample Kit of 12 disposable Unyvero LRT BAL Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit) | Unyvero | CURETIS GMBH |
| 2 | 04260364750041 | M1 Master Mix Tube Kit | 10020 | Kit of 12 Unyvero M1 Master Mix Tubes, to be used with Unyvero LRT Cartridges | Unyvero | CURETIS GMBH |
| 3 | 04260364750034 | LRT Cartridge Kit | 10049 | Kit of 12 disposable Unyvero LRT Cartridges, including sample tubes, sample tube Kit of 12 disposable Unyvero LRT Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit) | Unyvero | CURETIS GMBH |
| 4 | 04260364750027 | C8 Cockpit | 60003 | User interface and instrument to control Unyvero Application workflow in combina User interface and instrument to control Unyvero Application workflow in combination with Unyvero L4 Lysator(s) and Unyvero A50 Analyzer(s) | Unyvero | CURETIS GMBH |
| 5 | 04260364750010 | L4 Lysator | 60002 | Instrument to pre-process up to 4 samples for Unyvero Cartridges | Unyvero | CURETIS GMBH |
| 6 | 04260364750003 | A50 Analyzer | 60001 | Instrument to process 2 Unyvero Cartridges | Unyvero | CURETIS GMBH |
| 7 | 00815381020185 | RFIT-ASY-0145 | IVD reagent kit containing 6 tests | FilmArray® Pneumonia Panel (Pneumo) | BIOFIRE DIAGNOSTICS, LLC | |
| 8 | 00815381020178 | RFIT-ASY-0144 | IVD reagent kit containing 30 tests | FilmArray® Pneumonia Panel (Pneumo) | BIOFIRE DIAGNOSTICS, LLC |