QSN
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3988
- Medical specialty
- Microbiology
- FDA definition
- A qualitative nucleic acid assay that detects and identifies microbial organisms and antimicrobial resistance markers in clinical specimens to aid in the diagnosis of orthopedic infections.
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| Record | Firm | Date |
|---|---|---|
| BioFire Joint Infection (JI) Panel (DEN200066) | Biofire Diagnostics, LLC | 2022-04-29 |
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