Device |
influenza a virus subtype differentiation nucleic acid assay |
Definition |
A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza. |
Product Code | OEP |
Regulation Number |
866.3980
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Device Class |
2
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