Respiratory Test Kit Sofia® 2 Flu + SARS Antigen FIA 25 Tests CLIA Waived (M-1177399)

Name: TEST KIT, SOFIA FLU & SARS ANTIGEN FIA ASSY (25/KT 12KT/CS) • For use on Sofia 2 analyzers ONLY - test cannot be run on a Sofia 1 analyzer; reach out to your account manager with any analyzer questions or requests • Sofia 2 Flu + SARS Antigen FIA is for use under an FDA EUA: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations • Product ships with minimum 60 days dating • Emergency use of this test 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 high, moderate or waived complexity tests • 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner • The Sofia 2 Flu + SARS FIA is intended to be used with direct nasal or nasopharyngeal swabs and is not validated for use with viral transport media • The test is intended for use in the simultaneous rapid in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus nucleocapsid protein antigen , but does not differentiate, between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens • 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 • Laboratories within the United States and its territories are required to report all SARS-CoV-2results to the appropriate public health authorities • Negative results do not rule out COVID-19 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 the presence of clinical signs and symptoms consistent with COVID-19 • Negative SARS-CoV-2 results, from patients with symptom onset beyond five days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed • The Sofia 2 Flu + SARS Antigen FIA is intended for use on the Sofia 2 only and by medical professionals or trained operators who are proficient in performing tests using the Sofia 2 Instrument; the Sofia 2 Flu + SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization • Accurate detection with direct samples • Results in 15 minutes • 12-month shelf life from date of manufacture • 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner • Room temperature storage