For in vitro diagnostic use. System Digital LightCycler system IVD Digital LightCycler® System SYS_362 09274804001 Digital LC Analyzer Digital LC Analyzer 07613336175941 Instruments Not Available Not Available 09224777001 Digital LC Partitioning Engine Digital LC Partitioning Engine 07613336175934 Instruments Not Available Not Available The Digital LightCycler® System supports a semi-automated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT). The system performs digital endpoint PCR analysis of microfluidic partitions, combining the functionalities of instrumentation, consumables, reagents, and data management to provide an efficient workflow from sample partitioning to result interpretation.The Digital LightCycler® System is a semi-automated system for detection and absolute quantification of nucleic acid target copy number, intended for in vitro diagnostic use by professional users in diagnostic and screening laboratories.The system is comprised of the Digital LightCycler® Analyzer, the Digital LightCycler® Partitioning Engine, and specified consumables, core reagents and application software. All assays are developed independently of the Digital LightCycler® System. en The system is a nucleic acid quantification system that uses digital PCR technology (dPCR). The system partitions a sample into a large number of nanowells to allow for absolute quantification of a target nucleic acid sequence without a standard curve.The system allows for a wide range of applications, e.g., in oncology by analyzing cell-free DNA, rare mutations, copy number variations, and gene expression, or in infectious disease diagnostics by detection and quantification of low viral loads.The main features of the system are:Digital PCR technology (dPCR) for detection of low target concentrations6 fluorescence channels for multichannel detection3 analysis types (absolute quantification, CNV, indel)Workflows for diagnostic and development purposesDevelopment software for detailed data analysis5x concentrated DNA and RNA master reagents for higher sample fractionPartitioning of each sample into a large number of nanowells on a dedicated nanowell plateMerged lanes to emulate the partitioning of a larger sample volume into an even higher number of nanowells3 types of nanowell plates (universal, high resolution, high sensitivity) for different applicationsPartitioning of up to 8 samples on 1 nanowell plate in the partitioning engineProcessing of up to 96 samples on 12 nanowell plates on the analyzer en