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*The LumiraDx SARS-CoV-2 Ag 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.

EUA Status of LumiraDx SARS-CoV-2 Ag Test and LumiraDx SARS-CoV-2 Ab Test
The LumiraDx SARS-CoV-2 Ag Test and the LumiraDx SARS-CoV-2 Ab Test have not been cleared or approved by FDA. The LumiraDx SARS-CoV-2 Ag Test has been authorized by FDA under an EUA only for the detection of SARS-CoV-2 nucleocapsid protein. The LumiraDx SARS-CoV-2 Ab Test has been authorized by FDA under an EUA only for detecting the presence of total antibodies to SARS-CoV-2. They have not been authorized for use to detect any other viruses or pathogens. The Tests are authorized in the United States 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.