Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
Medical specialty
Microbiology
Device class
2
Regulation number
866.3988
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.