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

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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
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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 10000135541
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 In Vitro Diagnostic Medical Devices Directive (98/79/EC). The CFX Opus 96 Dx and CFX Opus 384 Dx Systems are for distribution and use in the countries of Austria, Belgium, Bulgaria, Croatia, Cyprus, The Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland.

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.

No rights are granted by Bio-Rad for the use of high-resolution melt analysis in the fields of human or veterinary in vitro diagnostics. In addition, it is the responsibility of the purchaser to obtain any intellectual property rights which may be required for its specific applications.

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