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

BIO-RAD LABORATORIES

Provides full range of instrumentation, reagent kits, software and quality control systems to clinical laboratories. ... read more Featured Products: More products

Download Mobile App





Bio-Rad’s CFX96 Dx Real-Time PCR System Listed with FDA for IVD Testing

By LabMedica International staff writers
Posted on 19 May 2020
Bio-Rad Laboratories, Inc.’s (Hercules, CA, USA) CFX96 Dx Real-Time PCR System has been listed with the US Food and Drug Administration (FDA) for IVD testing and may be used to help in the diagnosis of COVID-19.

Throughout the COVID-19 pandemic, the CFX96 Dx Real-Time PCR System has been used by laboratories outside the US that require an IVD platform to detect SARS-CoV-2. More...
The system has also met the CE mark requirements for IVD use in Europe and is registered with regulatory bodies for IVD use in many other countries. The FDA listing now extends access to the instrument to assay developers and testing laboratories in the US.

The CFX96 Dx Real-Time System joins other Bio-Rad products that are being used for the detection of COVID-19, including the company’s SARS-CoV-2 Droplet Digital PCR (ddPCR) Kit; Platelia SARS-CoV-2 Total Ab assay; and the SARS-CoV-2 Standard, which is used to support laboratory assay validation of COVID-19 testing.

"We are pleased our CFX96 Dx Real-Time PCR System is now available for COVID-19 testing in US markets," said Annette Tumolo, Bio-Rad Executive Vice President, President, Life Science Group. "By identifying those who test positive for the virus, individuals can be quarantined and receive treatment more quickly, helping to contain the spread of this disease."



Gold Member
Flu SARS-CoV-2 Combo Test
OSOM® Flu SARS-CoV-2 Combo Test
Online QC Software
Acusera 24•7
Steam Sterilizer
Hi Vac II Line
Clinical Informatics Platform
CLARION™
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 Credit: Shutterstock

Single Liquid Biopsy Predicts Early Immunotherapy Benefit in Advanced Lung Cancer

Assessing early benefit from immunotherapy in advanced non-small cell lung cancer can be challenging because radiographic responses may take months to become clear. Early scans can also be difficult to... Read more

Immunology

view channel
Image: Graphical Abstract (Morgane Fournier et al., Cell (2026). DOI: 10.1016/j.cell.2026.04.013)

Study Reveals Immune Mechanism Driving Severe COVID-19 Progression

Severe COVID-19 has highlighted gaps in understanding of early antiviral responses, particularly why some patients deteriorate despite timely care. Type I interferons are central to host defense, yet their... Read more

Microbiology

view channel
Image: Benchmarking design for systematic evaluation of PASEF acquisition strategies (Xian, F., Mitulovic, G., Ravi Kumar, R.K. et al.  Nature Communications. https://doi.org/10.1038/s41467-026-75845-5)

Proteomic Workflow Maps Microbial and Host Responses in Intestinal Inflammation

The intestinal microbiome influences digestion, metabolism, and immunity, yet its complexity makes functional measurements difficult to obtain. DNA surveys can indicate which organisms and potential pathways... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.