Device typeThermal cycler nucleic acid amplification analyser IVD, point-of-care: A portable, electrically-powered instrument intended to be used by healthcare professionals at the point-of-care 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 quantified 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.
FDA categoryRespiratory Virus Panel Nucleic Acid Assay System
Device IDB540FAB1100CWC0
Catalog numberFAB1100CW-1
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information