Respiratory Test Kit LumiraDx™ SARS-CoV-2 Ag 48 Tests CLIA Waived (M-1197690)

Name: REAGENT, SARS-COV-2 ANTIGEN TEST STRIP KIT (48TEST/EA) • The LumiraDx SARS-CoV-2 Ag Test is for use under an Emergency Use Authorization ONLY: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate, high or waived complexity tests • Product ships with minimum 60 days dating • This 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 identification of SARS-CoV-2 nucleocapsid protein antigen; antigen is generally detectable in nasal swab specimens during the acute phase of infection • 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 • Negative results, from patients with symptoms onset beyond twelve days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed • Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions • Negative results should be considered in the context of a patient’s recent exposures, history and presence of clinical signs and symptoms consistent with COVID-19 • The LumiraDx SARS-CoV-2 Ag Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings, and proficient in performing tests using the LumiraDx Instrument • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner • The workflow process is comprised of a simple sample prep along with step-by-step guidance of the Instrument to report a patient result in under 12 minutes from sample application • The LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2