OMS

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Novel Influenza A Virus, A/H5 Ns1 Protein

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3332

Medical specialty

Microbiology

FDA 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.

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