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

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/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
Gold Member
Universal Transport Solution
Puritan®UniTranz-RT
New
Electrolyte Analyzer
CBS-4000 (CBS-400)
New
Hematology Consumables
Bioblood Devices
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: Study results show blood protein levels change markedly in childhood and adolescence, with sex differences increasing with age (photo credit: Adobe Stock)

Proteomic Data Underscore Need for Age-Specific Pediatric Reference Ranges

Serum proteins underpin many routine tests used to detect inflammation, hormonal imbalance, cardiovascular disease, and metabolic disorders. Yet pediatric interpretation often relies on adult reference... Read more

Pathology

view channel
Image: Study flowchart. This study developed a multimodal artificial intelligence framework to predict PIK3CA mutations in breast cancer (Jiaxian Miao et al., Cancer Biol Med 23(3): 430–450 (2026). DOI: 10.20892/j.issn.2095-3941.2025.0771)

Multimodal AI Tool Predicts Genetic Alterations to Guide Breast Cancer Treatment

PIK3CA mutations are key biomarkers for selecting phosphoinositide 3-kinase (PI3K)–targeted therapies in breast cancer, yet access to molecular testing can be inconsistent and costly. Conventional polymerase... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.