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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeNXD
Regulation Number 866.3332
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTERS FOR DISEASE CONTROL AND PREVENTION
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT COMMAND
  SUBSTANTIALLY EQUIVALENT 1

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