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Product code OCC

Device name
Respiratory Virus Panel Nucleic Acid Assay System
Medical specialty
Microbiology
Device class
2
Regulation number
866.3980
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.
Source
FDA openFDA device classification dataset