Immunoassay Control Kit LumiraDx™ SARS-CoV-2 Ag Positive Level / Negative Level 4 X 0.5 mL (M-1197712)

Name: CONTROL, SARS-COV-2 ANTIGEN 2POS/2NEG .5ML • 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 • 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 • The LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2 • 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 • The LumiraDx SARS-CoV-2 Ag Quality Controls (hereafter referred to as Quality Controls) are liquid quality controls to be used with the LumiraDx Instrument (hereafter referred to as the Instrument) and the LumiraDx SARS-CoV-2 Ag Test (hereafter referred to as SARS-CoV-2 Ag Test) • The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip • 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 o • Kit contents: 2 X 0.5ml vial SARS-CoV-2 Ag Positive Control, 2 X 0.5ml vial SARS-CoV-2 Ag Negative Control, 24 Transfer pipettes (20µl), LumiraDx SARS-CoV-2 Ag Quality Control Pack Insert • Requires: LumiraDx Instrument, LumiraDx SARS-CoV-2 Ag Test Strips, and LumiraDx Connect– if connectivity required (refer to LumiraDx Connect User Manual)