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

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

NXD

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Class 2

21 CFR 866.3332

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Microbiology

Device Characteristics

No

No

No

Not Eligible

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.