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

      CFX_Opus_96_Dx_detail.jpg

      Overview

      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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      Description

      Description

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      CFX Opus 96 Dx and CFX Opus 384 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 can multiplex up to 5 targets per well and CFX Opus 384 Dx can multiplex up to 4 targets per well. 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
      Inquire for Ordering
      CFX96 Deep Well Dx System
      CFX Opus 384 Dx System
      Operational Manual | Data Sheet
      Inquire for Ordering
      Features Multiplex up to 5 targets per sample well on the CFX Opus 96 Dx and up to 4 targets per sample well on the CFX Opus 384 Dx.
      Optimize assay development with the thermal gradient function.
      Analyze and generate traceable, audit-ready reports with electronic signature functionality.

      CFX Opus Dx Instrument

      Licensed for PCR Yes  
      Dimensions (WxDxH) 33 x 56 x 36 cm / 13 x 22 x 14 in  
      Weight 22 kg / 48 lb  
      Touch screen Adjustable viewing angle from 15° to 22°C
      Lid temperature range Lid temperature range 30–110°C

      Sample Block

      Sample block type Fixed 96 well Fixed 384 well
      Consumables 96-well plates
      Single tubes, strip tubes      		 384-well plates
      Reaction volumes 1–50 µL
      (10–50 µL recommended)      		 1–30 µL
      (5–30 µL recommended)
      Maximum ramp rate 5°C/sec 2.5°C/sec
      Average ramp rate 3.3°C/sec 2°C/sec
      Thermal accuracy ±0.2ºC  
      Thermal uniformity ±0.3ºC  
      Gradient Operational temperature range: 30–100°C
      Programmable span: 1–24°C

      Optical Detection System

      Sensitivity 1 copy of target sequence in human genomic DNA
      Dynamic range 10 orders of magnitude
      Excitation / Emission Ranges 450–684 nm / 510–730 nm 450–650 nm / 515–690 nm
      Calibrated fluorophores Cal Gold 540, Cal Orange 560, Cal Red 610, Cy 5, Cy 5.5, FAM, HEX, Quasar 670, Quasar 705, ROX, Texas 615, VIC, SYBR, Texas Red Cal Gold 540, Cal Orange 560, Cal Red 610, Cy 5, FAM, HEX, Quasar 670, ROX, Texas 615, VIC, SYBR, Texas Red
      Scan time All channels: 12 sec
      FAM/SYBR: 3 sec      		 All channels: <20 sec
      FAM/SYBR: 8 sec
      Multiplex Up to 5 targets per well Up to 4 targets per well

      CFX Maestro Dx SE Software

      Operating system Windows 10 (64-bit)  
      Instrument control Connect up to 4 CFX Opus Dx systems (mix of CFX Opus 96 Dx and CFX Opus 384 Dx) directly via USB cable or through laboratory network via Ethernet cable
      Laboratory Information System compatible Yes
      Automation ready API
      21CFR Part 11 Assists with 21CFR Part 11 compliance through integrated secure username and password log-in, traceable audit-ready reports with electronic signature functionality
      Data analysis Allelic discrimination, End point, Gene expression, Quantification
      Graphics Bar charts, clustergrams, scatter plots
      Export formats CSV, Excel, RDML, Text, XML

      Documentation for CFX Opus Dx System

      Language CFX Opus Dx Operation Manual CFX Maestro Dx SE Software Guide
      Chinese 10000134783 10000135541
      Croatian 10000136677 10000136678
      Czech 10000135544 10000135545
      Danish 10000135546 10000135547
      English 10000135538 10000134781
      French 10000135550 10000135551
      German 10000135548 10000135549
      Greek 10000135617 10000135618
      Hungarian 10000135619 10000135620
      Indonesian 10000135621 10000135622
      Italian 10000135623 10000135624
      Japanese 10000135628 10000135629
      Korean 10000135630 10000135631
      Lithuanian 10000135632 10000135633
      Norwegian 10000135634 10000135635
      Polish 10000135636 10000135637
      Brazilian Portuguese 10000135640 10000135641
      Portuguese 10000135638 10000135639
      Romanian 10000135642 10000135643
      Spanish 10000135644 10000135645
      Swedish 10000135646 10000135647
      Thai 10000135648 10000135651
      Vietnamese 10000135652 10000135653
      Russian 10000135542 10000134784

      Legal Notice:
      CFX Opus 96 Dx System or CFX Opus 384 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 and CFX Opus 384 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 and CFX Opus 384 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 and CFX Opus 384 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 and CFX Opus 384 Dx Systems meet the requirements for distribution as an in vitro diagnostic instrument.

      Documents

      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
      10000135538
      CFX Opus Dx Operation Manual, English
      DHF-04581
      Declaration of Conformity, CFX Opus Dx