C. Difficile Nucleic Acid Amplification Test Assay
Medical specialty
Microbiology
Device class
1
Regulation number
866.2660
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.