ellume·lab is a versatile, handheld digital device designed for healthcare professionals at the point of care. ellume·lab offers a growing range of highly accurate, rapid diagnostic tests for the detection of common infectious diseases and provides practitioners with a suite of digital tools to support clinical decision-making and enhance patient engagement.
We are excited to be launching ellume·lab into the U.S. in 2021 with our FDA Emergency Use Authorized COVID Antigen test.*
The ellume·lab diagnostic test range includes qualitative immunoassay tests for the detection of common infectious diseases and biological markers.
Two tests can be performed at the same time, with simple, animated on-screen instructions and rapid results in 15 minutes.
The COVID Antigen test (for the detection of active COVID-19 infections) is currently available*. The COVID Serology test (for the detection of total antibodies to SARS-CoV-2) is pending regulatory clearance. Further tests, including a Flu A+B and a Flu A+B / RSV test, have undergone clinical studies and are being prepared for launch.
ellume·lab provides practitioners with a suite of digital tools to support clinical decision-making and enhance patient engagement, on the same device. All ellume·lab digital tools offer secure, HIPAA compliant cloud connectivity for sharing results with patients or other healthcare professionals.
The tools have been designed by doctors for intuitive and efficient clinician use, with patient needs in mind. Digital tools include a BMI and growth calculator, dosage calculator, clinical camera and gallery, and medical diagrams.
*This product has not been FDA cleared or approved, but has been authorized by the 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; and, 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.
