We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

ELITechGroup

Offers a range of products for in vitro diagnostics in clinical chemistry, hemostasis, microbiology, immunology, and ... read more Featured Products: More products

Download Mobile App





ELITechGroup’s Rapid Detection Test Kits Secure FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 21 Apr 2020
ELITechGroup MDx LLC (Puteaux, France), a global provider of diagnostic testing products, and its Korean partner, OSANG Healthcare (South Korea), have secured Emergency Use Authorization (EUA) from the FDA for its SARS-CoV-2 virus test for use in the US. More...


The GeneFinder 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 US. 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.

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 US.

"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."

"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."



Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
POC Helicobacter Pylori Test Kit
Hepy Urease Test
Pipette
Accumax Smart Series
Gel Cards
DG Gel Cards
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Molecular Diagnostics

view channel
Image: The blood-based DNA methylation test predicts lymph node metastasis in early-stage gastric cancer (Photo courtesy of Institute of Science Tokyo)

Blood Test to Help Low-Risk Gastric Cancer Patients Avoid Unnecessary Surgery

Accurately identifying lymph node metastasis in early-stage gastric cancer remains a major clinical challenge. CT imaging often misses up to half of lymph node–positive cases, leading clinicians to recommend... Read more

Hematology

view channel
Image: Research has linked platelet aggregation in midlife blood samples to early brain markers of Alzheimer’s (Photo courtesy of Shutterstock)

Platelet Activity Blood Test in Middle Age Could Identify Early Alzheimer’s Risk

Early detection of Alzheimer’s disease remains one of the biggest unmet needs in neurology, particularly because the biological changes underlying the disorder begin decades before memory symptoms appear.... Read more

Microbiology

view channel
Image: The SMART-ID Assay delivers broad pathogen detection without the need for culture (Photo courtesy of Scanogen)

Rapid Assay Identifies Bloodstream Infection Pathogens Directly from Patient Samples

Bloodstream infections in sepsis progress quickly and demand rapid, precise diagnosis. Current blood-culture methods often take one to five days to identify the pathogen, leaving clinicians to treat blindly... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.