51903135-65e4-49ec-a698-656d7ffdfdd3UpdatePublished52022-09-162016-09-122022-05-03Not in Commercial Distribution07332940003821PrimaryGS1GeneXpert Infinity-80 SystemINFINITY 80-24900-0496956711444CEPHEID1falsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse18888383222techsupport@cepheid.com48031Thermal cycler nucleic acid amplification analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.falseActiveOOIReal Time Nucleic Acid Amplification SystemStorage Environment Temperaturefalsefalse