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.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » BD Infectious Disease Test Gains Expanded CE Mark

BD Infectious Disease Test Gains Expanded CE Mark

December 29, 2021

Becton Dickinson (BD) has received a CE mark for its expanded BD COR system, which now includes MX, a new instrument for high-throughput molecular testing for infectious diseases.

The new instrument is based on the company’s BD MAX polymerase chain-reaction platform, a medium-throughput system intended for settings like hospital labs. BD plans to use the BD MAX menu of infectious disease tests to create assays that can be performed in high-throughput central reference labs.

The first test available on the MX instrument is the BD CTGCTV2, which detects the three most prevalent nonviral sexually transmitted infections — Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis.

View today's stories

Medical Devices Submissions and Approvals

Upcoming Events

  • 13Jul

    FDA Ad and Promo Enforcement Trends: Past, Present and Future

  • 27Jul

    Applying the Lessons of the Pandemic to Your Upcoming Trial

  • 28Jul

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments?

  • 02Aug

    Medical Device Cybersecurity: Understand the Latest Developments

  • 03Aug

    Pharmaceutical Process Validation: Best Practices for Success

  • 10Aug

    Gene & Cell Therapy Regulation: Comparability and Other New Developments

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • FDA Approves Foundation Medicine’s Companion Diagnostic for Genentech’s Rozlytrek

  • Novartis Pays $100 Million for Mallinckrodt’s Priority Review Voucher

  • FDA Approves Beyond Air’s LungFit PH for Newborn Pulmonary Hypertension

  • FDA Grants Priority Review to Roche’s Lunsumio for Follicular Lymphoma

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 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing