Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
PURITAN MEDICAL

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
Universal Transport Solution
Puritan®UniTranz-RT
Serological Pipet Controller
PIPETBOY GENIUS
New
Gold Member
Blood Gas Analyzer
Stat Profile pHOx
New
DNA/RNA Extraction/Purification Kit
Nucleic Acid Extraction or Purification Kit
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








DIASOURCE (A Biovendor Company)

Channels

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: A simple blood test could replace surgical biopsies for early detecion of heart transplant rejection (Photo courtesy of Shutterstock)

Blood Test Detects Organ Rejection in Heart Transplant Patients

Following a heart transplant, patients are required to undergo surgical biopsies so that physicians can assess the possibility of organ rejection. Rejection happens when the recipient’s immune system identifies... Read more

Pathology

view channel
These images illustrate how precision oncology Organ Chips recapitulate individual patients’ responses to chemotherapy (Photo courtesy of Wyss Institute at Harvard University)

Cancer Chip Accurately Predicts Patient-Specific Chemotherapy Response

Esophageal adenocarcinoma (EAC), one of the two primary types of esophageal cancer, ranks as the sixth leading cause of cancer-related deaths worldwide and currently lacks effective targeted therapies.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.