With a pipeline of 30+ assays, initially focused on some of the most common conditions being diagnosed or managed with point-of-care testing: Coagulation disorders, Infectious disease, Cardiovascular and Diabetes.
*Authorized by FDA under an EUA, **For surveillance use only, ***Not available in US.
Not all products are available in all countries and regions. Please check with your local LumiraDx sales representative or distributor for availability in specific markets.
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.
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.
Supporting healthier lives, for individuals, communities and wider society
Enabling responsive, personal relationships between patients and care teams.
Controlling and reducing costs to help ease pressure on healthcare budgets.