OMS

Novel Influenza A Virus, A/H5 Ns1 Protein

Product code

OMS

Device name

Novel Influenza A Virus, A/H5 Ns1 Protein

Device class

Class 2

21 CFR

21 CFR 866.3332

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).