LumiraDx Instrument for Rapid Detection of SARS-CoV-2

Innovative microfluidic technology delivers exceptional clinical performance in minutes, Used with the LumiraDx SARS-CoV-2 Ag Test

Supplier:  LumiraDx L001000330001

Catalog No. 22-181-000

Description

• Features:
  • Innovative, next generation point of care system that combines a small, portable instrument, advanced low-cost test strip and seamless digital connectivity
  • Delivers exceptional point of care clinical performance
  • Simple and easy to use
  • Performance referenced to laboratory test
  • Portable instrument, seamless connectivity
  • One simple, intuitive test workflow
  • Fast results in minutes
  • Nasal swab specimen type
  • Room temperature storage
  • Used with the LumiraDx SARS-CoV-2 Ag Test
• Notes:
  
  • Orders require executed contractual agreement
    • Please contact your Fisher Healthcare Account Representative for more information
  • This test has not been FDA cleared or approved; but has been authorized by FDA under EUA for use by authorized laboratories; use by laboratories certified under the CLIA, 42 U.S.C. §263a, that meet requirements to perform moderate, high or waived complexity tests
  • Test authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
  • Authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens
  • In USA, test is only authorized for duration of declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked sooner

Specifications

• Sample Type: Proteins from SARS to CoV to 2
• Description: Used with LumiraDx SARS-CoV-2 Ag Test
• Format: Portable instrument

Authorized under EUA for use by authorized labs, test has not been FDA cleared or approved