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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. Emergency use of this test is limited to authorized laboratories using the LumiraDx Platform. 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. Testing of fingerstick whole blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests. Testing of fingerstick whole blood 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. 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.
LumiraDx SARS-CoV-2 Ag Surveillance Test
The LumiraDx SARS-CoV-2 Ag Surveillance Test has not been cleared, approved, or authorized by FDA. This test should be used for surveillance purposes (i.e., to inform population or community-level decision-making on de-identified specimens) only. FDA does not regulate surveillance tests.