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Interim guidance for the detection of novel Influenza A virus using rapid influenza diagnostic tests
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August 10, 2009
[PDF-158.48 KB]
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Description:This guidance was revised to clarify that the current rRT-PCR developed by CDC to detect novel influenza A ( H1N1) is authorized by the FDA. The FDA authorization, also termed Emergency Use Authorization or EUA, is not equivalent to FDA cleared, which was incorrectly stated in the previous version of the guidance.
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Content Notes:Background -- Influenza Diagnostic Tests -- Rapid Influenza Diagnostic Tests -- The Role of RIDT for Detecting Novel H1N1: Clinical Considerations.
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