CFX Opus Dx Real-Time PCR Detection Systems for In Vitro Diagnostics (IVD)

CFX Opus 96 Dx, CFX Opus 384 Dx, and CFX Opus Deepwell Dx are open systems offering the ultimate flexibility in commercial assay selection or rapid assay development in a clinical laboratory setting. CFX Opus 96 Dx and CFX Opus Deepwell can multiplex up to 5 targets per well and CFX Opus 384 Dx can multiplex up to 4 targets per well. CFX Opus Dx portfolio provides options to address multiple thruputs and sample volumes. The instruments offer precise quantification, accurate thermal cycler performance and powerful easy-to-use software.

System Comparison

	CFX Opus 96 Dx System Operational Manual Data Sheet Inquire for Ordering	CFX Opus 384 Dx System Operational Manual Data Sheet Inquire for Ordering	CFX Opus Deepwell Dx Operational Manual Data Sheet Inquire for Ordering
Features	Multiplex up to 5 targets per sample well on the CFX Opus 96 Dx and CFX Opus Deepwell Dx. The CFX Opus 384 can detect up to 4 targets per sample well. CFX Opus 384 Dx provides our highest throughput while CFX Opus Deepwell Dx accommodates larger sample volumes in a 96-well format. Optimize assay development with the thermal gradient function. Analyze and generate traceable, audit-ready reports with electronic signature functionality.

Documentation for CFX Opus Dx System

Supporting Documents

• Approved Importers

Legal Notice:

CFX Opus 96 DX System, CFX Opus 384 Dx System, or CFX Opus Deepwell Dx System with CFX Maestro Dx SE Software are intended to perform fluorescence-based PCR to detect and quantitate nucleic acid sequences. The systems and software are intended for in vitro diagnostic use by trained laboratory technicians. The systems are intended to be used with third-party diagnostic nucleic acid tests which have been manufactured and labeled for diagnostic purposes.

USA: For In Vitro Diagnostic Use. The CFX Opus 96 Dx, CFX Opus 384 Dx, and CFX Opus Deepwell Dx Systems meet the requirement for distribution as an in vitro diagnostic device under the US FDA.

Canada: For In Vitro Diagnostic Use. The CFX Opus 96 Dx, CFX Opus 384 Dx, and CFX Opus Deepwell Dx Systems meet the requirement for distribution as an in vitro diagnostic device under Health Canada.

Europe: For In Vitro Diagnostic Use. The CFX Opus 96 Dx, CFX Opus 384 Dx, and CFX Opus Deepwell Dx Systems meet the requirement of the European In Vitro Diagnostic Regulation (2017/746).

Singapore:For In Vitro Diagnostic Use. The CFX Opus 96 Dx, CFX Opus 384 Dx, and CFX Opus Deepwell Dx Systems meet the requirements for distribution as an in vitro diagnostic instrument.