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

QuidelOrtho

Develops, manufactures and markets rapid diagnostic tests that focus on infectious diseases, reproductive health, and... read more Featured Products: More products

Download Mobile App




Quidel Receives Amended FDA Emergency Use Authorization for New AI-Powered Sofia Q Rapid Antigen Test Device

By LabMedica International staff writers
Posted on 15 Jun 2021
Quidel Corporation (San Diego, CA, USA) has received an amended Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) allowing the company to market Sofia Q, its latest addition to the Sofia and Sofia 2 line of Fluorescent Immunoassay Analyzers (FIA). More...


Sofia Q utilizes Sofia fluorescent technology to provide an accurate, objective, and automated result in 15 minutes. Sofia Q features a sleek, miniaturized design that reads the same Sofia SARS Antigen FIA tests as Sofia and Sofia 2 - with equal accuracy. Quidel’s innovative design allows the Sofia Q device to be paired with the downloadable Sofia Q mobile application, which guides the user through the workflow and interprets the test result using a proprietary AI model. Sales of Sofia Q device will initially be limited to use with the Sofia SARS Antigen FIA in the CLIA and CLIA-waived professional segments.

“Sofia Q is our latest powerful diagnostic instrument designed to democratize access to the many benefits of our Sofia SARS rapid antigen tests and, ultimately, our full portfolio of Sofia tests for influenza, RSV, Strep and other conditions,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “We designed Sofia Q to be very affordably priced and conducive to widespread adoption across the ever-expanding global point-of-care and telemedicine marketplace. In the future, we believe Sofia Q will be ideal to serve consumers at home, as well as in schools and workplaces.”



Gold Member
Immunochromatographic Assay
CRYPTO Cassette
Collection and Transport System
PurSafe Plus®
Capillary Blood Collection Tube
IMPROMINI M3
New
Gold Member
Hybrid Pipette
SWITCH
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

Hematology

view channel
Image: A schematic illustrating the coagulation cascade in vitro (Photo courtesy of Harris, N., 2024)

ADLM’s New Coagulation Testing Guidance to Improve Care for Patients on Blood Thinners

Direct oral anticoagulants (DOACs) are one of the most common types of blood thinners. Patients take them to prevent a host of complications that could arise from blood clotting, including stroke, deep... Read more

Microbiology

view channel
Image: EBP and EBP plus have received FDA 510(k) clearance and CE-IVDR Certification for use on the BD COR system (Photo courtesy of BD)

High-Throughput Enteric Panels Detect Multiple GI Bacterial Infections from Single Stool Swab Sample

Gastrointestinal (GI) infections are among the most common causes of illness worldwide, leading to over 1.7 million deaths annually and placing a heavy burden on healthcare systems. Conventional diagnostic... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.