Respiratory Test Kit Lucira™ COVID-19 and Flu Home Test 1 Test per Kit

Features

• Lucira by Pfizer COVID-19 & Flu Home Test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA): https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#individual-molecular
• The Lucira by Pfizer COVID-19 & Flu Home Test is a single use (disposable) home test kit intended for simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral nucleic acid
• This test is authorized for non-prescription home use with anterior nasal swab samples from individuals 14 years or older (self-collected) or individuals 2 years or older (collected by an adult) with signs and symptoms consistent with a respiratory tract infection, including COVID-19
• Positive results indicate the presence of viral nucleic acid, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status
• Positive results do not rule out bacterial infection or co-infection with other pathogens not detected by the test.
• Negative results for SARS-CoV-2 and influenza B are presumptive, meaning that they should be confirmed, if necessary for patient management, with an authorized or cleared molecular test performed in a CLIA-certified laboratory that meets requirements to perform high or moderate complexity tests
• Negative results do not rule out SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for treatment or other management decisions, including infection control decisions
• This Lucira by Pfzer COVID-19 & Flu Home Test contains everything needed to perform one (1) Lucira by Pfzer COVID-19 & Flu Home Test: Instructions, 2 AA Batteries, 1 test unit, 1 sample vial, 1 sterile nasal swab and 1 disposal bag

More Information

• Luciera COVID-19 & Flu Home Test FDA EUA Letter
• Lucira COVID-19 & Flu Home Test IFU
• Lucira COVID-19 & Flu Home Test Healthcare Professionals Fact Sheet
• Luciera COVID-19 & Flu Home Test Quick Ref