Who we are Request Info Case Studies News & Events Careers Investors Knowledge Center US Transforming community-based healthcare through a next generation Point of Care diagnostic Platform Lab-comparable performance at speed Leverages testing methodologies used in lab analyser systems, enabling healthcare providers to deliver lab-comparable performance and real-time results at the point of care Broad test menu pipeline Improved economic value Introducing our high sensitivity, LumiraDx Platform. A next generation point of care diagnostic system, that combines a small, portable Instrument; microfluidic Test Strip; simple, standardized workflow; and seamless, secure digital connectivity to the Cloud and hospital IT systems. Latest FDA Reissues LumiraDx Fast Lab Solutions’ EUA for SARS CoV-2 RNA STAR Complete Molecular Reagents to Allow High Throughput and Asymptomatic Testing Solutions Read more Results at your fingertips Lab comparable results in minutes from a small sample EXPLORE INSTRUMENT *Not available in US *Not available in US *Authorized by FDA under an EUA *Authorized by FDA under an EUA On-the-spot testing Currently offering SARS-CoV-2 Antigen and Antibody, D-Dimer and INR test capabilities, with a pipeline of over 30 tests across a range of assay technologies including enzyme, immunoassay, molecular and electrolyte assays. All carried out on one, easy to use device. EXPLORE TEST MENU SARS CoV-2 Ag *Authorized by FDA under an EUA SARS CoV-2 Ab *Authorized by FDA under an EUA Surveillance Test *For surveillance use only D-Dimer *Not available in US INR *Not available in US Well connected Our latest Cloud-based technology empowers healthcare professionals with effortless data reporting, analytics, and decision support. EXPLORE CONNECTIVITY Our platform is designed to be affordable and accessible at the point of care Emergency department Primary care Health clinic Retail pharmacy SEE ALL NEWS FDA Reissues LumiraDx Fast Lab Solutions’ EUA for SARS CoV-2 RNA STAR Complete Molecular Reagents to Allow High Throughput and Asymptomatic Testing Solutions Read more LumiraDx Reports Third Quarter 2021 Financial Results Read more LumiraDx to Announce Third Quarter 2021 Financial Results and Host Quarterly Conference Call on November 10 Read more INQUIRE NOW 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. Want to be kept informed of the latest LumiraDx developments? Better Health Supporting healthier lives, for individuals, communities and wider society Who we are Request Info Case Studies News & Events Careers Investors Instrument Test Menu Connectivity Care Solutions Testing in Action Customer Services Fast Lab Solutions Facebook LinkedIn Twitter Legal Information UK Addresses © 2021 LumiraDx. All rights reserved, worldwide. Registration Number: 09206123. About Cookies On This Site We use technologies to personalize and enhance your experience on our site. Visit our Privacy Policy to learn more or manage your personal preferences in our Tool. By using our site, you agree to our use of these technologies. Accept Manage Cookies