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





Snibe Diagnostic’s Maglumi 2019-nCoV IgM/IgG Test Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 21 Sep 2020
Snibe Diagnostic (Shenzhen, China) has received Emergency Use Authorization from the US Food and Drug Administration for its SARS-CoV-2 antibody test.

Snibe’s Maglumi 2019-nCoV IgM/IgG test comprises a capture chemiluminescence immunoassay for immunoglobulin M antibodies against SARS-CoV-2 and an indirect chemiluminescence immunoassay for immunoglobulin G antibodies against the virus. More...
The test uses human serum and serum in separating gel tube samples and runs on the company's Maglumi 2000 series fully automated chemiluminescence immunoassay analyzer. The test can be used by any lab certified to perform moderate- or high-complexity tests, according to the FDA.

Snibe had received CE marking for the Maglumi 2019-nCoV IgM/IgG test in February. In August, the company also received CE marking for its fully automated quantitative serology test for detecting IgG antibodies against SARS-CoV-2S-RBD, the receptor-binding domain of the S protein.

Related Links:
Snibe Diagnostic


Gold Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
βeta-Hydroxybutyrate Reagent
β-Hydroxybutyrate LiquiColor®
Urine Analyzer
respons® UDS100
Portable POCT Blood Gas Analyzer
BD100
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: Acute lymphoblastic leukemia in children and young people requires careful relapse risk assessment as treatment expands beyond standard chemotherapy. (Image Credit: Shutterstock)

New Risk-Stratification Tool Predicts Relapse After Blinatumomab in Childhood ALL

Acute lymphoblastic leukemia in children and young people requires careful assessment of relapse risk, particularly as treatment approaches move beyond standard chemotherapy. Traditional relapse predictors... 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

Microbiology

view channel
Image Credit: Adobe Stock

Decentralized Laboratory Network Improves Detection of Viral Hemorrhagic Fevers in Guinea

Viral hemorrhagic fevers remain a major diagnostic challenge in West Africa because their early symptoms can resemble those of other febrile illnesses. The 2014–2016 Ebola epidemic underscored the need... Read more

Pathology

view channel
Image: The CE-marked software IVD combines digital histopathology and clinicopathological data to generate a prognostic classification (Image Credit: Shutterstock)

Digital Pathology Test Stratifies Recurrence Risk in Early Breast Cancer

In hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer, accurate recurrence-risk assessment helps guide treatment decisions. However, individual risks... Read more

Technology

view channel
Image: Diatech Pharmacogenetics launches Labcycler, a compact PCR thermal cycler. (Photo courtesy of Diatech Pharmacogenetics)

Compact PCR Thermal Cycler Launches for Routine Molecular Laboratory Workflows

Molecular laboratories rely on nucleic acid analysis to detect molecular information accurately and reproducibly across a wide range of applications. Supporting these routine workflows, a newly launched... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.