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U.S. Department of Health and Human Services

Product Classification

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Device nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna
Regulation Description Reagents for detection of specific novel influenza A viruses.
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.
Physical State OIVD
Technical Method Direct nucleic acid amplification
Target Area specific RNA segment
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeNXD
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3332
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Documents
  • Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses
  • Reagents for Detection of Specific Novel Influenza A Viruses : Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document
Third Party Review Not Third Party Eligible
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