NXD

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

Product code

NXD

Device name

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

Device class

Class 2

21 CFR

21 CFR 866.3332

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and differentiation of specific rna gene segments 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. These reagents are primers and probes, along with a specific novel influenza virus control.

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