510(k) DEN200066
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 29, 2022
- Date Received
- October 27, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
- Device Class
- Class II
- Regulation Number
- 866.3988
- Review Panel
- MI
- Submission Type
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.