For in vitro diagnostic use. Instrument LumiraDX IVD LumiraDx Instrument INS_7781 10 417 749 174 10417749174 LumiraDx Instrument V5E (JP) LumiraDx Instrument V5E (JP) 05060537710242 Meters L001000313001 Not Available Not Available 10 417 749 039 10417749039 LumiraDx Instrument V5E (RO) LumiraDx Instrument V5E (RO) 05060537710334 Meters L001000328001 Not Available Not Available 10 417 749 160 10417749160 LumiraDx Instrument V5E (EN,US) EUA LumiraDx Instrument V5E (EN,US) EUA 05060537710303 Meters L001000330001 Not Available Not Available 10 417 749 060 10417749060 LumiraDx Instrument V5E (NO) LumiraDx Instrument V5E (NO) 05060537710181 Meters L001000307001 Not Available Not Available 10 417 749 038 10417749038 LumiraDx Instrument V5E (FR) LumiraDx Instrument V5E (FR) 05060537710136 Meters L001000302001 Not Available Not Available 10 417 749 026 10417749026 LumiraDx Instrument V5E (DK) LumiraDx Instrument V5E (DK) 05060537710204 Meters L001000309001 Not Available Not Available 10 417 749 050 10417749050 LumiraDx Instrument V5E (IT) LumiraDx Instrument V5E (IT) 05060537710150 Meters L001000304001 Not Available Not Available 10 417 749 054 10417749054 LumiraDx Instrument V5E (NL) LumiraDx Instrument V5E (NL) 05060537710211 Meters L001000310001 Not Available Not Available 10 417 749 003 10417749003 LumiraDx Instrument V5E (DE) LumiraDx Instrument V5E (DE) 05060537710143 Meters L001000303001 Not Available Not Available 10 417 749 059 10417749059 LumiraDx Instrument V5E (SE) LumiraDx Instrument V5E (SE) 05060537710174 Meters L001000306001 Not Available Not Available 10 417 749 018 10417749018 LumiraDx Instrument V5E (EN) LumiraDx Instrument V5E (EN) 05060537710129 Meters L001000301001 Not Available Not Available 10 417 749 058 10417749058 LumiraDx Instrument V5E (FI) LumiraDx Instrument V5E (FI) 05060537710198 Meters L001000308001 Not Available Not Available 10 417 749 047 10417749047 LumiraDx Instrument V5E (PT-BR) LumiraDx Instrument V5E (PT-BR) 05060537710259 Meters L001000326001 Not Available Not Available 10 417 749 046 10417749046 LumiraDx Instrument V5E (PT-EU) LumiraDx Instrument V5E (PT-EU) 05060537710228 Meters L001000311001 Not Available Not Available 10 417 749 036 10417749036 LumiraDx Instrument V5E (ES) LumiraDx Instrument V5E (ES) 05060537710167 Meters L001000305001 Not Available Not Available The LumiraDx Instrument is intended for use with the LumiraDx family of Test Strips for the in vitro measurement of various analytes in a range of biological samples by trained healthcare professionals. en

LumiraDx Instrument

IVD

LumiraDx instrument capillary finger stick application or nasal swab sample application

Reshaping the healthcare journey for you and your patients at the Point of Need with LumiraDx

LumiraDx puts powerful diagnostics in your hands. The portable, multimodal system is designed to make testing easy, efficient and more accessible. With a simple instrument workflow and no need for phlebotomy there are minimal training requirements. Nine assays let you gain fast, reliable results from a simple finger stick or nasal swab sample right at the Point of Need - for actionable insights in minutes where you want them.

Powered by actively controlled microfluidic technology, this cutting-edge system supports testing across various conditions, specimen types, and technologies all within a compact, user-friendly instrument.¹

LumiraDx features at a glance

One system many possibilities

With nine assays that help you to detect and treat some of the most burdensome conditions, LumiraDx becomes your trusted daily companion in primary care and other decentralized settings.

True portability

The instrument is compact, lightweight and battery powered¹ with room temperature storage of tests^2-10. LumiraDx can be used right where the patient is, making diagnostics accessible in a wide range of settings.

Simple workflow

The intuitive, standardized interface on LumiraDx provides step-by-step guidance throughout the testing process, making it easy to use and easy to learn. The fast, reliable, connected results support clinical decision-making at the point of need.¹

Benefits at a glance

More flexibility and improved access to care at the Point of Need

Portable

Compact, lightweight and battery-powered¹
No need for test refrigeration just room temperature storage^2-10
Convenient and flexible with everything you need in one carry case¹

Consolidate clinical chemistry and immunoassay tests on one system

Versatile

Perform multiple tests on a single instrument¹
Nine assays enable you to detect and treat infectious and cardiovascular diseases, diabetes and coagulation disorders^2-10
Grow your capabilities as new assays are added

Easy to use with minimal training

Simple

Multiple sample types, including direct finger stick and swab samples, no phlebotomy required and only one drop to run a test¹
A simple and intuitive user interface provides step-by-step guidance through the easy-to-learn test workflow¹

Fast results help support quicker treatment decisions

Impactful

Actively controlled microfluidic technology uniting diagnostic testing across a wide range of disease areas, technologies and specimen types¹
Reduce unnecessary follow-up visits, patient wait times and support quicker treatment decisions with rapid results at the Point of Need^11,12,13
Enhance efficiency and optimize care pathways^11,12,13

Connectivity for centralized control of decentralized testing

Connected

Remotely manage and configure instruments¹⁴
Manage and demonstrate policy compliance¹⁴
Secure, simple workgroup provisioning¹⁴
Secure integration into the patients electronic records¹⁴

Actively controlled microfluidics technology

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Show video transcript

The future of diagnostics.

It is never compromising speed for Reliability.
It's testing for multiple analytes within a single user-friendly system and getting results you can trust within minutes.
It's point of care that can go almost anywhere.

It's LumiraDx, a next generation diagnostics system that combines a broad test menu across a wide range of disease areas by leveraging the power of actively controlled microfluidics. LumiraDx consolidates the diagnostic technologies from multiple point of care systems into a small portable instrument to deliver both speed and performance in minutes. The LumiraDx test strip was engineered to be universally applicable across different types of diseases, technologies, and specimen types, and efficient for manufacturing in high volumes.

Here's how it works.

Once a single droplet of a specimen is added to the test strip and detected, the active microfluidics take over, distributing the specimen into channels so that the specimen and reagents can be mixed and assays and onboard controls can be run simultaneously.

Let’s take the example of the SARS-CoV-2 antigen test strip.

Inside the strip two assay particles, one magnetic and one fluorescent, are actively mixed with a specimen and bind with any target antigen present to create a sandwich complex. In the reading zone, a magnetic field grabs a hold of such sandwich complexes, while an air wash removes any residual sample and unbound fluorescent particles. This ensures a clear signal for optical determination of whether the antigen is present in the specimen.

The on-screen results can then be sent electronically to the patient's record. The instrument is designed to run a variety of different assay formats and specimen types. LumiraDx diagnostic testing solutions are being deployed globally by governments, leading health care institutions, pharmacies, care homes and community outreach programs. It's compact enough to deliver reliable results almost anywhere because the future of diagnostics should be one that benefits everyone, everywhere. LumiraDx, next generation point of care.

Overview

Ordering Information

The ability to determine NT-proBNP with just a drop of blood from the fingertip has proven to be a very convenient and modern solution for both us and our patients. In particular, we notice improved time efficiency and better communication with our patients. Testing with a point-of-care system allows us to make quick clinical decisions that we can discuss immediately with our patients and from which a therapeutic decision of further diagnostics can be derived immediately. With our approach, we help to minimize referrals to cardiology specialists with long waiting times and recurring hospital admissions. There are associated cost savings for the healthcare system by initiating therapy at an early stage.

Dr Stefan Bauernschmitt

Internist, sports and emergency physician and lead at GP group practice “med. In”, Germany

Related products

LumiraDx training center

Get the most out of the LumiraDx system with these helpful instructional videos to support the proper use of the Instrument and assays, including setup, connectivity, correct sample application and assay training videos.

View now

Learn more now

Contact information for ordering, billing, and technical support for LumiraDx products

Country	Ordering Email	Ordering Telephone	Technical Support Email	Technical Support Telephone
Austria	wien.bestellung_aut@roche.com	+43 1 277 87 420	techsupport_lumira.at@roche.com	+43 1 277 87 555
France	meylan.commandes@roche.com		techsupport_lumira.fr@roche.com	+33 0485380126
Germany	mannheim.auftragsbearbeitung@roche.com		techsupport_lumira.de@roche.com	+49 621 759 79314 +49 621 759 4747
Italy	monzadia.customercare@roche.com	+39 800 620 621	techsupport_lumira.it@roche.com	+39 800 620 626
Japan	tokyo.rdkk-ord@roche.com	+81 03 6634 1065	techsupport_lumira.jp@roche.com	+81 0120-642-860
South Africa	rrd.customer_services@roche.com	+27 11504 4777	techsupport_lumira.za@roche.com	+27 10056 3556
Sweden	roche.kundsupport@roche.com	+46 84048871	techsupport_lumira.se@roche.com	+46 840 488 74
UK	burgesshill.customerservice@roche.com	+44 808 100 99 98	techsupport_lumira.uk@roche.com	+44 808 100 99 98
USA	customerservices.us@lumiradx.com	+1 888 586 4721	technicalservices.us@lumiradx.com	+1 888 586 4721
Other countries			techsupport_lumira.global@roche.com	+44 127 302 61 28

Contact us

Do you have questions about our products or services? We’re here to help. Contact a Roche representative in your region.

References

LumiraDx Platform User Manual V5E English (version 11, 2023-07)
LumiraDx Product Insert Nt-proBNP (version 3, 2023-07)
LumiraDx Product Insert HbA1c (version 8, 2024-01)
LumiraDx Product Insert CRP (version 5, 2024-02)
LumiraDx Product Insert D-Dimer (version 11, 2023-07)
LumiraDx Product Insert INR (vers vion 4, 2024)
LumiraDx Product Insert SARS-CoV-2 Ag Ultra (version 1, 2022-07)
LumiraDx Product Insert SARS-CoV-2 Ag (version 14, 2022)
LumiraDx Product Insert SARS-CoV-2 & RSV (version 3, 2023-08)
LumiraDx Product Insert SARS-CoV-2 & Flu A/B (version 5, 2022)
Bachtiger P, Kelshiker MA, Petri CF, et al. Survival and health economic outcomes in heart failure diagnosed at hospital admission versus community settings: a propensity-matched analysis. BMJ Health Care Inform. 2023 Jan 28;30(1):e100718.
Price CP, Fay M, Hopstaken RM. Point-of-Care Testing for D-Dimer in the Diagnosis of Venous Thromboembolism in Primary Care: A Narrative Review. Cardiol Ther. 2021 Oct 23 ;10(1):27-40.
Patzer KH, Ardjomand P, Göhring K, et al. Implementation of HbA1c Point of Care Testing in 3 German Medical Practices: Impact on Workflow and Physician, Staff, and Patient Satisfaction. J Diabetes Sci Technol. 2018;12(3):687-694.
LumiraDx Connect User Manual (version 7, 2025-01)

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