FDA Grants CorDx Emergency Use Authorization for Multi-Target Rapid Test for Flu A/B & COVID-19
SAN DIEGO, CA / ACCESSWIRE / March 27, 2024 / CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and other medical devices, recently received Emergency Use Authorization (EUA)?for its CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test.
The 3-in-1 multiplex test is a lateral flow immunoassay device intended for the qualitative detection and differentiation of nucleocapsid protein antigen from SARS-CoV-2, influenza type A, and influenza type B. Samples are collected directly from nasal swabs sourced from those suspected of respiratory viral infection. The novel 10-minute diagnostic solution sets the standard in both detecting and distinguishing between Flu A, Flu B, and COVID-19.
CorDx's Tyfast Flu A/B & COVID-19 Multiplex Rapid Test is designed for professional use at the point-of-care (POC)-administered by healthcare professionals or other individuals trained in patient-care settings. The test has only been authorized for in-vitro diagnostic use under an EUA and has not been FDA cleared or approved.
Multiplex testing provides rapid diagnostic results at the point-of-care, especially as respiratory viruses surge. With influenza and COVID-19 cases climbing, the test gives labs and healthcare providers an efficient and accurate diagnostic solution. CorDx's high-performance multiplex test delivers results in just 10 minutes-offering a fast and accessible alternative to conventional testing methods.
"We are pleased to receive Emergency Use Authorization for our Tyfast Flu A/B & COVID-19 Multiplex Rapid Test," said Aiiso Li, CorDx's Founder and CSO. "While the test is currently authorized for POC use, we hope it will be granted OTC authorization in the near future, giving families and communities yet another way to prioritize their health."
For more information about CorDx's Tyfast Flu A/B & COVID-19 Multiplex Rapid Test, or to inquire about distribution opportunities, visit CorDx.com.
About CorDx:
CorDx, a global biotechnology organization, is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world. CorDx develops, manufactures, and distributes diagnostics and related tools that empower users to monitor and improve their health. Its proprietary diagnostic solutions are recognized by families and medical professionals for being affordable, use-friendly, and precise. To learn more, visit CorDx.com.
Contact Information
Gabriel Alvarado
Sales Manager
gabriel@cordx.com
+1(858)5682095
SOURCE: CorDx
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