Device typeMultiple antimicrobial resistance 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 multiple genes conferring resistance to multiple antimicrobial drugs in multiple types of bacteria present in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Genes detected may include, but are not limited to, carbapenemase genes (KPC, NDM, VIM, and OXA), extended spectrum beta-lactamase (ESBL)-encoding genes (e.g., TEM, SHV, IMP, NDM-1 and CTX-M) and/or vancomycin resistance genes (vanA and vanB).
FDA categorySystem, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen, System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
Device ID07332940001032
Catalog numberGXCARBAR-10
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information