Device typeClostridium difficile nucleic acid IVD, kit, nucleic acid technique (NAT): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers from Clostridium difficile bacteria in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Markers detected may include genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027) and genes encoding toxin A and/or B.
FDA categoryC. Difficile Nucleic Acid Amplification Test Assay, C.Difficile Toxin Gene Amplification Assay
Device IDB178GBCDIFF100
Catalog numberGBCDIFF-10
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information