Research use only CDC flu SC2 multiplex assay primers and probes
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Research use only CDC flu SC2 multiplex assay primers and probes

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      Updated July 13, 2021 Reagents manufactured from these sequences may not be used for diagnostic testing under FDA’s authorization of the CDC Flu SC2 Multiplex Assay. Only primers and probes labeled for EUA use and distributed by the International Reagent Resourceexternal icon may be used for diagnostic testing with the CDC Flu SC2 Multiplex Assay. These oligonucleotide sequences are intended to be used for the purposes of respiratory virus surveillance and research. The recipient agrees to use them in compliance with all applicable laws and regulations. Every effort has been made to assure the accuracy of the sequences, but CDC cannot provide any warranty regarding their accuracy. The recipient can acknowledge the source of sequences in any oral presentations or written publications concerning the research project by referring to the Genomics and Diagnostics Team, Virology Surveillance and Diagnosis Branch, Influenza Division, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA. CDCSARS2FluAB@cdc.gov Should the recipient use these sequences in the design of a diagnostic device, the device developed from these sequences and the use of primers and probes synthesized from these sequences is not authorized under CDC’s Flu SC2 Multiplex Assay EUA. The device would be considered a new and separate test from the Flu SC2 Multiplex Assay and must comply with applicable laws and regulations. CDC has extended an open right of reference to CDC’s EUA for the Flu SC2 Multiplex Assay. Any recipient seeking FDA authorization for a device based in whole or in part on the design of the CDC Flu SC2 Multiplex Assay is welcome to reference the CDC EUA (EUA 201781) in their application.
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