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SARS-CoV-2

Test Information
Home / Systems / GeneXpert Family of Systems / GeneXpert Omni

GeneXpert® Omni System

A Portable Molecular Diagnostic System That Delivers Lab Quality Results Wherever Clinicians Need Them

GeneXpert<sup>®</sup> Omni System

Introducing the GeneXpert® Omni

Compact Design – Optimized to fit anywhere testing is needed

Standardized Technology – Lab quality PCR results

Integrated Battery – Supports over 2 hours of mobile operation

Xpert® Xpress SARS-CoV-2 Test – Results available in as soon as 30 minutes*

Intuitive User Interface – Easy to use mobile device supports simplified workflow

*With Early Assay Termination (EAT) for positive results. Approximately 45 minutes for negatives.This product (GeneXpert Omni) and test (Xpert Omni SARS-CoV-2) have not been FDA cleared or approved. This product has been authorized by FDA for use with the Xpert Omni SARS-CoV-2 test under an Emergency Use Authorization (EUA). This product has been authorized only for use with the Xpert Omni SARS-CoV-2 test for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test has been authorized by FDA under an EUA for use by authorized laboratories. This product and test are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
 
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