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.
Integrates several technologies and sample types into a single Instrument, allowing for a continued development of a broad test menu across conditions diagnosed and managed in community-based healthcare settings.
Replaces multiple point of care systems with a single Platform, increasing efficiency through reduced training, equipment, maintenance and test supplies.
LumiraDx’s next generation, point of care diagnostic Platform is designed to be affordable and accessible for healthcare providers globally and intends to strengthen community-based healthcare.
Download The Free Reports
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.