Respiratory Test Kit Lucira™ COVID-19 / Flu A + B 1 Test

Features

• The LUCIRA by Pfizer COVID-19 & Flu Test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
• The Lucira by Pfizer COVID-19 & Flu Test is a rapid, instrument-free, single-use molecular diagnostic test for the qualitative detection of SARS-CoV-2, Influenza A, and Influenza B RNA from anterior nasal swab samples in individuals with known or suspected COVID-19 or flu
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests
• The Lucira by Pfizer COVID-19 & Flu Test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
• Results are for the simultaneous detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in clinical specimens and is not intended to detect Influenza C virus
• Positive results are indicative of the presence of SARS-CoV-2, Influenza A, and/or Influenza B RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient 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 and should be confirmed with an alternative molecular FDA-cleared or authorized assay
• Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities
• As a single-use test, LUCIRA® by Pfizer makes it easy to onboard molecular testing technology: no calibration, no on-going maintenance, and no extensive training needed for your staff
• For Use under Emergency Use Authorization (EUA) only
• For in vitro Diagnostic Use
• Rx Only

More Information

• Lucira COVID-19 & Flu FDA EUA Letter
• Lucira COVD-19 & Flu IFU
• Lucira COVID-19 & Flu Healthcare Providers Fact Sheet
• Lucia COVID-19 & Flu Patients Fact Sheet
• Lucira COVID-19 & Flu Sales Sheet