QSN · Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Microbiology · 21 CFR 866.3988 · Class 2
Overview
| Product Code | QSN |
|---|---|
| Device Name | Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System |
| Regulation | 21 CFR 866.3988 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN200066 | BioFire Joint Infection (JI) Panel | Biofire Diagnostics, LLC | Apr 29, 2022 | DENG |
Top Applicants
- Biofire Diagnostics, LLC — 1 clearance
