software modifications / sample processing / data management / qualitative in vitro diagnostic device / multiplex test systems / marketed predicate device / cleared devices / treatment for the misidentified viral illness / /
MedicalCondition
unnecessary infection / disease / respiratory virus infection / active infection / Influenza A / Health Respiratory illness / actual infection / nonviral infections / RSV viral pneumonia / high risk infection / specific influenza A / bacterial infection / Parainfluenza / viral pneumonia / respiratory infection / misidentified viral illness / influenza / respiratory viral infection / serious infection / /
MedicalTreatment
vaccination / /
Organization
Radiological Health Office / U.S. Department of Health and Human Services / Advisory Committee on Immunization Practices / Food and Drug Administration / Division of Dockets Management / Food and Drug Administration Center for Devices / FDA / In Vitro Diagnostic Device Evaluation and Safety Division of Microbiology Devices Preface Public Comment Written / Centers for Disease Control and Prevention / / /
Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay