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.
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The LumiraDx SARS-CoV-2 Ag test has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
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.