•FebriDx is not intended to diagnose any specific bacteria or virus, including SARS-CoV-2.
•The test is intended for professional use and should be used in conjunction with other clinical evidence including laboratory, radiographic, and epidemiological information.
•Negative results do not preclude respiratory infection and should not be used as the sole basis for diagnosis, treatment, or other clinical and patient management decisions. In addition to utilizing radiography and clinical presentation to aid in diagnosis, additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and polymerase chain reaction [PCR]) may be used to confirm the presence of a specific respiratory pathogen.
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