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

Legal Notice:

The Platelia SARS-CoV-2 Total Ab Assay has been authorized by the FDA under an EUA for use by authorized laboratories. The test has not been FDA cleared or approved. The test has been authorized only for the presence of total antibodies against SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

*The Platelia SARS-CoV-2 Total Ab Assay Test has also met requirements for applying the CE-Mark in Europe and other certifications throughout the world (Brazil ANVISA, Health Canada, Singapore HSA, etc.).

The Platelia SARS-CoV-2 Total Ab Assay has been authorized by the FDA under an EUA for use by authorized laboratories. The test has not been FDA cleared or approved. The test has been authorized only for the presence of total antibodies against SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The Platelia SARS-CoV-2 Total Ab Assay Test has also met requirements for applying the CE-Mark in Europe and other certifications throughout the world (Brazil ANVISA, Health Canada, Singapore HSA, etc.).

USA: This Reliance SARS-CoV-2 RT-PCR Assay Kit has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by the authorized laboratory. This test has been authorized only for the detection of nucleic acid from SARS CoV-2, not for any other viruses or pathogens, and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

USA: The Reliance SARS-CoV-2/Flu A/Flu B RT‑PCR Assay Kit has not been FDA cleared or approved. This kit has been authorized by the FDA under an EUA for use by the authorized laboratory. This test has been authorized only for the detection of nucleic acids from SARS-CoV-2, influenza A, influenza B, and not for any other viruses and pathogens, and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or Diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C.  § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Europe: The Reliance SARS-CoV-2 RT-PCR Kit (IVD) and the Reliance SC2/Flu A/Flu B RT‑PCR Kit (IVD) is for use in the European Union only with CE-IVD marked In Vitro Diagnostic Medical Devices. These kits are CE Marked for sale outside the U.S., with limited regional availability. Please check with your local sales office.

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.