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#1001198202 | Mfg #L001000330001 | Clinical Laboratory

Point-of-Care Diagnostic Platform LumiraDx™

INSTRUMENT, LUMIRADX
Point-of-Care Diagnostic Platform LumiraDx™

The LumiraDx Platform is an innovative, next generation point of care system that combines a small, portable instrument, advanced low cost test strip and seamless digital connectivity

Product Specifications

MSFH #
1001198202
Manufacturer #
LumiraDx Inc, LumiraDx™, L001000330001, Unknown
Brand
Point-of-Care Diagnostic Platform
Manufacturer
73 X 97 X 210 mm
Country of Origin
For use with LumiraDx Test Strips / LumiraDx Connect
Application
50/60Hz, 100 to 240V, Touchscreen Display
Dimensions
Capillary Blood Sample / Nasal Swab Sample
For Use With
SARS-CoV-2 Ag
Power Source
SARS-CoV-2 Ab
Readout Type
D-Dimer
Sample Type
Prothrombin Time (INR)
Test Name
Surveillance
UNSPSC Code
41115819
User Interface
High Contrast Touch Screen / Barcode Scanner
Weight
2.42 lbs.

Description

Enzyme and immunoassay on a single platform

Its proprietary technology enables it to deliver exceptional point of care clinical performance, while being simple and easy to use

Performance referenced to laboratory test

Portable instrument, seamless connectivit

One simple, intuitive test workfow

Fast results in minutes

All common clinical samples

Small sample size including capillary blood

Ability to perform Quality Control Tests using LumiraDx Quality Control to meet regulatory compliance requirements

2 x USB ports, RFID reader 13.56 MHz, 0 dBi (EIRP), Bluetooth low-energy 2.4 GHz ISM band, 2400 MHz to 2483.5 MHz, 0.5 dBm (ERP)

Lithium ion polymer 7.4 V 5000 mAh battery

High contrast touchscreen with a wide viewing angle

Uses small sample volumes and multiple convenient sample types, including nasal swab and capillary blood

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

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

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