Respiratory Test Kit Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test 1 Test per Kit

Features

• CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test is for use under an FDA Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• The CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens
• This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older
• This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests
• 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
• All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
• Negative results do not rule out SARS-CoV-2, influenza A, and influenza B infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions such as isolating from others and wearing masks
• Easy to use design, effortless self-administration, whether at home or on the go
• Swift Clarity: Receive results rapidly in 10 minutes for early decision-making

More Information

• TyFast Flu A+B and COVID-19 Home Test FDA EUA Letter
• Tyfast Flu A+B and COVID-19 Home Test IFU
• Tyfast Flu A+B and COVID-19 Home Test Healthcare Providers Fact Sheet
• Tyfast Flu A+B and COVID-19 Home Test Quick Ref Instructions