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U.S. Department of Health and Human Services

Product Classification

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Device novel influenza a virus, a/h5 ns1 protein
Regulation Description Reagents for detection of specific novel influenza A viruses.
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.
Physical State OIVD
Technical Method Immunoassay using PDZ domains in intracellular receptors to capture influenza A/H5 NS1 protein
Target Area PDZ ligands (PL) of NS1 protein
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOMS
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3332
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible