LumiraDx Platform, a high sensitivity point of care diagnostic testing system

$3500.0
Brand
LumiraDX
Unit Type
Unit
Custom Bundle
No
Model
LumiraDx Platform
MPN
L001000301001
Country/Region of Manufacture
United Kingdom
Unit Quantity
1
Modified Item
No
Intended Use/Discipline
Biological Laboratory, Cardiology, Emergency Medicine, Endocrinology, Immunology, Internal Medicine, Medical Laboratory, Microbiological Laboratory
condition
New

(Selling instrument only, does not come with test strips. 4 in factory box, 2 never opened and 2 opened but not used)Point of care testing system that is currently offering COVID-19 Antigen and Antibody test capabilities, with a pipeline of over 30 tests across a range of assay technologies including enzyme, immunoassay, molecular and electrolyte assays. All carried out on one, easy to use device.
Test strip information: https://www.lumiradx.com/us-en/test-menu

No need for multiple diagnostic instruments

This single, easy to use, portable Instrument has a simple and consistent workflow for all tests and is designed for intuitive use - simply follow the on-screen video display for high-sensitivity results in minutes.

Connect Manager cloud-based services provide all capabilities to remotely manage and configure Instruments, view test results and simplify workgroup provisioning from a mobile, tablet or PC.

EHR Connect enables the transfer of results from the Instrument to the patient’s records

The LumiraDx Instrument can be used in 3 modes:

  • Standalone
  • Managed
  • EHR Connected (LIS or HIS compatible) Connectivity user documents

Limited FDA approval in US. 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.