Respiratory Test Kit FlowFlex™ COVID-19 Antigen OTC 300 Tests per Case / 1 Test per Box CLIA Waived (M-1204466)

Name: TEST KIT, COVID-19 FLOWFLEX ANTIGEN OTC (300TEST/CS) • Flowflex Covid-19 Antigen Home test is for use under an FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2 • Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection • Product ships with minimum 60 days dating • This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older • Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status • Positive results do not rule out bacterial infection or co-infection with other viruses • Individuals who test positive should self-isolate and consult their healthcare provider as additional testing may be necessary and for public health reporting • Negative results are presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed • Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19 • Clinical performance showed 93% sensitivity and 100% specificity