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, **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.
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.