SARS-CoV-2 / COVID-19 Diagnosis & Confirmation Solutions

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SARS-CoV-2 Testing Over the Course of Viral Infection​

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Legal Notice:

The CFX96 Dx System is intended for use in the fields of research and human in vitro diagnostics. The system is CE-IVD marked in compliance with the European Union diagnostic medical device manufacturing standards.

Europe: For in vitro diagnostic use. The CFX96 Dx System and CFX96 Deep Well Dx System meet the requirements of the In Vitro Diagnostic Medical Devices Directive (98/79/EC). The CE IVD, CFX96 Dx and CFX96 Deep Well Dx Systems are for distribution and use in specific European countries only (Austria, Belgium, Bulgaria, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovenia, Spain, and Sweden).

USA: For In Vitro Diagnostic Use. The CFX96 Dx and CFX96 Deep Well Dx Systems are registered with the US FDA as Class II 510(k) exempt devices.

China: The CFX96 Deep Well Dx System is registered for In Vitro Diagnostic use.

Worldwide: The CFX96 Dx and CFX96 Deep Well Dx Systems are registered for In Vitro Diagnostic use in the following countries: Argentina, Australia, Belarus, Bolivia, Brazil, Brunei, Chile, Colombia, Costa Rica, Dominican Republic, Egypt, Hong Kong, India, Laos, Morocco, New Zealand, Norway, Pakistan, Philippines, Qatar, S. Korea, Saudi Arabia, Singapore, Switzerland, Taiwan, Thailand, The Netherlands, Turkey, United Kingdom, Ukraine, Vietnam, and Yemen.

These products and/or their use are covered by claims of U.S. patents, and/or pending U.S. and non-U.S. patent applications owned by or under license to Bio-Rad Laboratories, Inc. Purchase of a product includes a limited, non-transferable right under such intellectual property for use of the product for internal research and diagnostic purposes only. No rights are granted for use of a product for commercial applications of any kind, including but not limited to manufacturing, quality control, or commercial services, such as contract services or fee for services. Information concerning a license for such uses can be obtained from Bio-Rad Laboratories. It is the responsibility of the purchaser/end user to acquire any additional intellectual property rights that may be required.

Kits and reagents are sold for research use only. Not for use in diagnostic procedures.

BIO-RAD is a trademark of Bio-Rad Laboratories, Inc. in certain jurisdictions.