Device typeMDR-TB/XDR-TB 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 genes conferring resistance to antimicrobial drugs, from bacterial species of the Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. bovis Bacillus Calmette-Guerin, M. africanum, M. canetti, M. microti, M. caprae and M. pinnipedi) in a clinical specimen and/or culture isolate, as a marker for multi-drug resistant tuberculosis (MDR-TB) or extensively drug-resistant tuberculosis (XDR-TB), using a nucleic acid technique (NAT).
FDA categorySystem, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
Device ID07332940000912
Catalog numberGXMTB/RIF-US-10
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information