The system is CE-IVD marked in compliance with the European Union diagnostic medical device manufacturing standards.Įurope: For in vitro diagnostic use. The CFX96 Dx System is intended for use in the fields of research and human in vitro diagnostics. Please check with your local sales office.
These kits are CE Marked for sale outside the U.S., with limited regional availability. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.Įurope: 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. 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. This kit has been authorized by the FDA under an EUA for use by the authorized laboratory. USA: The Reliance SARS-CoV-2/Flu A/Flu B RT‑PCR Assay Kit has not been FDA cleared or approved. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 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. This test has been authorized by the FDA under an EUA for use by the authorized laboratory. USA: This Reliance SARS-CoV-2 RT-PCR Assay Kit has not been FDA cleared or approved. 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 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 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. 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 has not been FDA cleared or approved. Some photos may be stock photos to get an idea of what is being offered for sale.Īny weights and dimensions provided in the listing are estimates so therefore you should not rely on them for the most accurate shipping quotation.įor more information on this Bio-Rad CFX96 Real-Time PCR or other used laboratory equipment please contact us at +1-85.The Platelia SARS-CoV-2 Total Ab Assay has been authorized by the FDA under an EUA for use by authorized laboratories. The photos provided are given to display the overall condition of the equipment and all items found in the photos may not be included in the sale. The written description provided for this equipment is what is being offered for sale.
BIO RAD CFX96 LICENSE
Typically any warranty, service contract or license for the equipment is not transferable but may be under certain circumstances and will be explicitly stated in the listing. It is encouraged that you inspect this equipment if possible. This Bio-Rad CFX96 Real-Time PCR is being sold “as is, where is” unless otherwise noted. This Bio-Rad CFX96 Real-Time PCR comes complete with C1000 Touch Thermal Cycler.
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