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





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

By HospiMedica 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
STI Test
Vivalytic Sexually Transmitted Infection (STI) Array
Antipsychotic TDM Assays
Saladax Antipsychotic Assays
New
POC Respiratory/Sore Throat Test
BIOFIRE SPOTFIRE (R/ST) Panel
New
X-Ray Generator
Advantage Plus Generators
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to HospiMedica.com and get access to news and events that shape the world of Hospital Medicine.
  • Free digital version edition of HospiMedica International sent by email on regular basis
  • Free print version of HospiMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of HospiMedica International in digital format
  • Free HospiMedica 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

Surgical Techniques

view channel
Image: The device combines a minimally invasive, long‑lifetime “read/write” brain‑computer interface (BCI) with assistive devices and AI-driven support (photo courtesy of Epia Neuro)

Implantable Brain-Computer Interface Supports Stroke Recovery and Assistive Function

Stroke leaves many survivors with chronic motor deficits that limit independence, and cognitive decline is a growing concern in aging populations. Stroke is a leading cause of long-term disability in the... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.