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

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

CFX Opus Dx Real-Time PCR Systems combine the flexibility you need in your workflow and outstanding performance to deliver reliable results that your clinical laboratory demands.

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Overview

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

 
CFX96 Dx System

CFX Opus 96 Dx System

Operational Manual
Data Sheet
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CFX96 Deep Well Dx System

CFX Opus 384 Dx System

Operational Manual
Data Sheet
Inquire for Ordering
CFX Opus Deepwell Dx

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

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.

Documents

Number Description Options
7456
CFX Opus 96 Dx Real-Time PCR System Product Information Sheet
7462
CFX Opus 384 Dx Real-Time PCR System Product Information Sheet
3402
CFX Opus Deepwell Dx Real-Time PCR System Product Information Sheet
10000135538
CFX Opus Dx Operation Manual, English
3617
Advancing Pharmacogenomics from the Bench to the Clinic with qPCR — Insights from Astrid Irwanto, Cofounder and COO of NalaGenetics
DHF-04581
Declaration of Conformity, CFX Opus Dx
10000134781
CFX Maestro Dx SE Software Guide, English
3525
A qPCR Comparability Study to Demonstrate the Analytical Equivalence of CFX96 Deep Well Dx and CFX Opus Deepwell Dx Systems
3570
Validation of Nala PGx Core® on CFX Opus 96 Real-Time PCR (RUO) and the CFX Opus 96 Dx (IVD) Real-Time PCR Systems