BOTHELL, Wash., April 20, 2020 /PRNewswire/ -- ELITechGroup MDx LLC, a leading global provider of diagnostic testing products, and its Korean partner, OSANG Healthcare, announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its SARS-CoV-2 virus test for use in the United States.
The GeneFinderTM COVID-19 Plus RealAmp Kit provides a fast and easy-to-use diagnostic solution to rapidly identify clusters of infection and has been validated using the ABI 7500 thermocycler and Bio-Rad CFX96 cycler – both popular Polymerase Chain Reaction (PCR) instruments found in diagnostics laboratories throughout the country.
Delivering qualitative results within hours, the highly sensitive testing kit requires a single tube rather than multiple reactions and uses Aveolar fluid, throat swab or sputum samples in a PCR instrument to detect the virus.
"The dramatic explosion of the novel coronavirus is affecting lives in every state," said ELITechGroup CEO, Christoph Gauer. "Hospitals and labs need access to reliable COVID-19 test kits, and we are here to support the medical professionals on the front lines working to prevent the spread of COVID-19."
To date, ELITechGroup has delivered more than 700,000 COVID-19 CE-IVD tests worldwide that have proven effective in accurately detecting the infection. ELITechGroup MDx is the exclusive distributor of the test kits to certain markets across the United States.
"We are determined to fight COVID-19 and the alarming infection rates now being seen in the U.S.," said OSANG Healthcare Chairman Dong-Hyun Lee. "We are pleased to partner with ELITechGroup MDx to bring much needed testing kits to U.S. shores."
To learn more or to order the COVID-19 Detection Kit for your lab or hospital, call 800-453-2725 or email at [email protected].
For more information about ELITechGroup MDx in the Unites States, please visit ELITechGroup.com/North-America/.
About ELITechGroup MDx LLC:
ELITechGroup is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents. By bringing together IVD specialty companies that offer innovative products and solutions, ELITechGroup has become a major contributor in advancing clinical diagnostics to laboratories in the proximity market, those operating closer to the patient.
About OSANG Healthcare:
OSANG Healthcare is a manufacturer of IVD (In-Vitro Diagnostics) Medical Devices of multiple fields ranging from Biochemistry, Immunoassay, and Molecular Diagnostics distributing globally to 100+ countries for over 23 years. By utilizing our in house innovation, OSANG Healthcare is dedicated to providing the most accurate, affordable, and real-time results at Point-of-Care (POC).
SOURCE ELITechGroup MDx LLC