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
Sekisui Diagnostics

Download Mobile App





Siemens Secures New FDA Emergency Use Authorizations for Coronavirus Antibody Test

By LabMedica International staff writers
Posted on 11 Jun 2020
Siemens Healthineers (Erlangen, Germany) has been granted Emergency Use Authorizations (EUAs) by the US Food and Drug Administration (FDA) for its total antibody test to detect the presence of SARS-CoV-2 antibodies running on the company’s Dimension Vista and Dimension EXL analyzers.

The FDA has granted EUA to Siemens’ Dimension Vista SARS-CoV-2 total antibody assay and Dimension EXL SARS-CoV-2 total antibody assay in order to identify people with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. More...
Both the products are sandwich-based chemiluminescent immunoassays.

Siemens had been developing the total antibody assay for use on its Dimension analyzers as well as on the company’s Advia Centaur and Atellica analyzers. Siemens had secured two EUAs for its laboratory-based total antibody test in May – one for use on the company’s Advia Centaur XP and Advia Centaur XPT systems, and the second for use on its Atellica next-generation system.




Gold Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
βeta-Hydroxybutyrate Reagent
β-Hydroxybutyrate LiquiColor®
Automated Urinalysis Solution
UN-9000
New
Slide Scanner System
NanoZoomer S540MD
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

Clinical Chemistry

view channel
Image: Blood proteins measured years before diagnosis may signal future prostate cancer risk, including aggressive disease.(Image Credit: iStock)

Blood Proteins Reveal Signals Linked to Prostate Cancer Risk Years Before Diagnosis

Prostate cancer is the most commonly diagnosed cancer in men worldwide. While many tumors grow slowly, aggressive forms can be life-threatening, underscoring the need for earlier risk identification.... Read more

Immunology

view channel
Image Credit: iStock

Antibody Profiling Predicts Inflammatory Bowel Disease Years Before Diagnosis

Inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis, involves abnormal immune responses that cause persistent inflammation and damage in the digestive system.... Read more

Pathology

view channel
Image Credit: iStock

AI Tissue Analysis May Help Identify Missed Precancerous Colon Polyps

Colorectal cancer is diagnosed in an estimated 1.9 million people worldwide each year, often without symptoms in its early stages. Timely detection of precancerous lesions is therefore important, yet some... Read more

Technology

view channel
Image: Signals LabGistics uses AI to turn natural-language instructions and SOPs into coordinated scientific workflows, helping connect teams, systems, and processes. (Photo courtesy of Revvity)

New AI-Powered System Aims to Streamline Laboratory and Manufacturing Workflows

Scientific laboratories supporting drug development, biotechnology, and materials research increasingly rely on coordinated digital workflows to move data, samples, and activities across teams.... Read more

Industry

view channel
Image: Beginning in 2027, Quest will provide access to the Onclarity Self-Collection Kit through clinician, health plan, and consumer-initiated testing channels, along with its patient service center network.

Collaboration to Expand Cervical Cancer Screening Access With At-Home HPV Collection

Cervical cancer is largely preventable with regular screening and early detection of human papillomavirus (HPV), the leading cause of the disease. Screening gaps persist, in part because traditional sample... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.