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Device influenza a and influenza b multiplex nucleic acid assay
Regulation Description Respiratory viral panel multiplex nucleic acid assay.
Definition An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.
Product CodeOZE
Regulation Number 866.3980
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTERS FOR DISEASE CONTROL AND PREVENTION
  SUBSTANTIALLY EQUIVALENT 3
QUIDEL CORP.
  SUBSTANTIALLY EQUIVALENT 2

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