*Authorized by FDA under an EUA
*Authorized by FDA under an EUA
*Not available in US
*Not available in US

Tried & tested

Providing lab comparable results for COVID-19 testing in minutes

Antigen and Antibody results on a single platform

*Not available in US*Not available in US*Authorized by FDA under an EUA*Authorized by FDA under an EUA

Stripped back

No need for multiple diagnostic instruments.

With a pipeline of 30+ assays, initially focused on some of the most common conditions being diagnosed or managed with POC testing

  • Coagulation disorders
  • Infectious disease
  • Cardiovascular
  • Diabetes

Test Features

  • Uses small sample volumes and multiple convenient sample types, including nasal swab and capillary blood
  • Potential for broad menu of tests on single instrument
  • Delivers diagnostic results in minutes
  • Results are compared to standard laboratory reference methods
  • On board haematocrit determination integrated into some tests
  • Room temperature storage
  • Liquid quality controls are available
Inquire now

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.

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.

BetterHealthExperiencesOutcomes

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.