FLUXERGY’S COVID-19 SAMPLE-TO-ANSWER-RT-PCR
TEST IS CURRENTLY UNDER EVALUATION

Fluxergy Submits Request for FDA Emergency
Use Authorization (EUA) for One-Hour COVID-
19 Test at Point-of-Care

EUA Application Follows Completion of Test Validation with Patient Samples by Physician - Scientists at UC San Diego

IRVINE, CA., March 30, 2020 - Fluxergy , a research and medical diagnostic test company based in Irvine California, has submitted an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administrator (FDA) Center For Devices and Radiological Health, seeking an Authorization that would permit medical professionals to begin using the company's high-speed Research Use Only (RUO) test system as a COVID-19 diagnostic at the point-of-care (POC).

Researchers AT UC San Diego Evaluating
Potential "One-Hour" COVID-19 Diagnostic Test
Developed By Irvine-Based Innovator Fluxergy

New coronavirus test may be able to confirm COVID-19 in under one hour at the point of care (patient's bedside)

IRVINE, Calif., March 17, 2020 -- Physician-scientists at the University of California, San Diego (UCSD) are the first to evaluate a new diagnostic testing system designed by Irvine, CA-based Fluxergy, that holds promise for identifying the SARS-Cov-2 virus (also known as the novel coronavirus) in as little as 45 minutes and typically within one hour.

CONTACT US ABOUT OUR COVID-19
SAMPLE-TO-ANSWER-RT-PCR TEST*

REQUEST COVID-19 SAMPLE-TO-ANSWER-RT-PCR
TEST INSTRUCTIONS FOR USE AND
ASSAY PERFORMANCE*

*Fluxergy’s products are for Research Use Only (RUO) and are not for use in diagnostic procedures. Fluxergy’s products are not yet cleared by the FDA or USDA for in vitro diagnostic use. None of the statements made on this website have been endorsed by the FDA or USDA.