Pfizer (Lab) 00069970131 - Respiratory… | USA MedPremium
Respiratory Test Kit Lucira™ COVID-19 / Flu A + B 1 Test per Kit
USAMP#66791439SKU: 00069970131Lucira™
Product Spotlight
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
