Respiratory Test Kit Lucira
COVID-19 / Flu A + B
1 Test per Kit
Pfizer 00069970131

Respiratory Test Kit Lucira
COVID-19 / Flu A + B
1 Test per Kit
Pfizer 00069970131

This item could be sold only to specialists with valid license after verification and is not returnable .

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

Manufacturer # 00069970131 Brand Lucira™ Manufacturer Pfizer (Lab) Country of Origin Unknown Application Respiratory Test Kit Contents 1 (1) Test Unit with Lyophilized Reagents and Electronic Readout, (1) Nasal Swab (Sterile Flocked Swab in Peel-Pouch), (1) Single Use Sample Vial, (2) AA Batteries for Test Unit, (1) Plastic Disposable Bag, Package Insert NDC Number 00069970131 Number of Tests 1 Test per Kit

Purchase Program Type Standard Purchase Reading Type Visual Read Sample Type Anterior Nasal Swab Sample Specialty Molecular Technology RT-LAMP Amplification Technology Test Format Test Device Format Test Kit Type Rapid Test Method Nucleic Acid Amplification Test (NAAT) Test Name COVID-19 / Flu A + B Test Type Molecular Diagnostic Time to Results 30 Minute Results