inforMED
NXDClass II

Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna

Microbiology · 21 CFR 866.3332

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.

MDR events0All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances3All time

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Recalls

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Registered firms

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