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U.S. Department of Health and Human Services

Product Classification

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Device influenza a virus subtype differentiation nucleic acid assay
Regulation Description Respiratory viral panel multiplex 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.
Physical State OIVD
Technical Method Direct nucleic acid detection
Target Area Specific RNA segments
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOEP
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3980
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Documents
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Assays [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm180306.htm] 
  • Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm180307.htm] 
Third Party Review Not Third Party Eligible
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