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*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.
EU: 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.
China: The CFX96 Deep Well Dx System has been certified as a Class III medical device by China National Medical Products Administration (NMPA) and is available for sale.
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.
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.
EU: 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.
China: The CFX96 Deep Well Dx System has been certified as a Class III medical device by China National Medical Products Administration (NMPA) and is available for sale.
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.