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

FDA product code NXD · 2 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3332
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2008-09-30 – 2010-07-06

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.

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