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LumiraDx Inc Respiratory Test Reader LumiraDx™ CLIA Waived - Each - L001000330001-EA

LumiraDx Inc Respiratory Test Reader LumiraDx™ CLIA Waived - Each - L001000330001-EA

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LumiraDx Inc Respiratory Test Reader LumiraDx™ CLIA Waived

Item Id 1198202
MF Id# L001000330001
Brand LumiraDx™
Manufacturer LumiraDx Inc
Country of Origin Unknown
Analyzer Type Benchtop
Application Respiratory Test Reader
CLIA Classified CLIA Waived
Dimensions 73 X 97 X 210 mm
For Use With For use with LumiraDx Test Strips / LumiraDx Connect
Is_Active_Vendor Y
Is_DSCSA N
Is_Discontinued N
Is_Medical_Device N
Lot_Tracking_Flag N
On_Allocation N
Power Source 100 to 240V, 50/60Hz
Purchase Program Type Standard Purchase Agreement
Readout Type Touchscreen Display
Sample Type Capillary Blood Sample / Nasal Swab Sample
Supplier_ID 67246160
Test Name SARS-CoV-2 Ag, SARS-CoV-2 Ab, D-Dimer, Prothrombin Time (INR), Surveillance
UNSPSC Code 41115819
User Interface High Contrast Touch Screen / Barcode Scanner
Weight 2.42 lbs.

Features

  • 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
  • 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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