We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Roche Rolls Out Cobas Testing Systems in CE Mark Countries

Roche Rolls Out Cobas Testing Systems in CE Mark Countries

September 3, 2014

Roche is now selling its Cobas 6800 and 8800 molecular testing systems for blood and plasma donor screening in countries that accept the CE mark, the company said Tuesday.

The new systems, which are available in medium and high throughput models, are also designed for viral load monitoring, women's health and microbiology testing.

According to Roche, the Cobas systems offer the fastest time to results with the highest throughput available, with each system delivering results for the first 96 tests in less than 3.5 hours. During an eight-hour shift, the 6800 System will provide up to 384 results, while the 8800 will yield 960.

The Cobas systems also allow for long walk-away time — up to eight hours for the 6800 and four hour for the 8800, the company says. The systems are based on polymerase chain reaction technology, which increases automation and workflow efficiencies and adapts to changing testing demands, the company adds.

Along with the 6800 and 8800 systems, Roche is launching the Cobas p 680 instrument, to support creation of donor sample pools, and three assays for donor screening: the Cobas MPX, WNV and HEV. A fourth assay, the Cobas DPX, will launch later this year. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.

Medical Devices Commercial Operations

Upcoming Events

  • 10Mar

    FDA Drug GMP Facility Inspections During the Pandemic

  • 16Mar

    Pharmaceutical Naming Regulation: Understanding the Latest Developments

  • 18Mar

    Pharmaceutical Postmarket Surveillance: Latest Developments in the Era of COVID-19

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 30Mar

    Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges

  • 06Apr

    Medical Device Cybersecurity: Understand the Latest Developments

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Acquires -Acquired

    Amgen to Buy Five Prime Therapeutics for $1.9 Billion

  • abbott-logo.gif

    Abbott Secures EUA for COVID-19 Combination Test

  • Eli Lilly logo

    Eli Lilly’s COVID-19 Antibody and Combo Therapy Gets Positive EMA Recommendation

  • AdaptiveBiotechnologies_Logo.png

    FDA Grants EUA for Adaptive Biotechnologies’ T Cell COVID-19 Test

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing