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U.S. Department of Health and Human Services

Medical Devices

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FDA Clears New CDC Test to Detect Human Influenza

Source: Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) at the Food and Drug Administration (FDA), September 30, 2008

The FDA cleared for marketing the new test developed by the U.S. Centers for Disease Control and Prevention (CDC) to diagnose human influenza infections and the highly pathogenic influenza A (H5N1) viruses.

The test, called the Human Influenza Virus Real-Time RT-PCR Detection and Characterization Panel (rRT-PCR Flu Panel), uses a molecular biology technique to detect flu virus and differentiate between seasonal and novel influenza.