QBH
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Lower Respiratory Microbial Nucleic Acid Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3985
- Medical specialty
- Microbiology
- FDA definition
- Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Unyvero LRT BAL Application (K191967) | Curetis GmbH | 2019-12-20 |
| Curetis Unyvero LRT Application (DEN170047) | Curetis GmbH | 2018-04-03 |
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