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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device novel influenza a virus, a/h5 ns1 protein
Regulation Description Reagents for detection of specific novel influenza A viruses.
Definition Novel influenza A virus reagents are used to directly detect and differentiate novel influenza A virus specific nonstructural protein 1 (NS1) in human respiratory specimens or viral cultures. Detection and differentiation of specific NS1 protein aids in the diagnosis of influenza caused by novel influenza A viruses in patients with clinical and epidemiological risk of infection with these viruses. They also aid in the presumptive identification of specific novel influenza A viruses and provide epidemiological information on influenza.
Product CodeOMS
Regulation Number 866.3332
Device Class 2

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