Immunoassay Control Kit LumiraDx™ SARS-CoV-2 Ag Positive Level / Negative Level 4 X 0.5 mL (M-1176896)

Name: CONTROL, SARS-COV-2 ANTIGEN 2POS/2NEG .5ML (CVS) • This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations • For use by laboratories certified under the CLIA, 42 U.S.C. §263a, that meet 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 • This test has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes 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 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 • 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, Quality Control package insert