FDA Clears CDC's MDx Test for H1N1 Virus | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared a test developed by the US Centers for Disease Control and Prevention for the diagnosis in humans of the 2009 H1N1 Influenza, making it the second to receive clearance, CDC said on Tuesday.

The test, called the CDC Influenza 2009 A (H1N1) pdm Real-Time PCR Panel, replaces an earlier test by CDC, also based on real-time RT-PCR technology, which received emergency authorization by the FDA in April, 2009.

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