Infinicyt™ CE-IVD

Last update: May 15th, 2021

At Cytognos we are continuously working to provide better solutions to improve patient care and enhance the efficiency of processes at the flow cytometry laboratory. In line with these objectives, we have released a new version of our software, Infinicyt™ 2.0.5 CE-IVD Edition in compliance with the European Directive 98/79/EC.

Which functionalities are CE-IVD?

The automated analysis in Infinicyt™ including the Automated Gating & Identification (AG&I) and Compass Classification tools and the following EuroFlow™ Databases:

  Type of sample Performance evaluation* AG&I AG&I + Compass

* Detailed information about performance evaluation included in the document: Instructions For Use (IFU) (see below).

Why use Infinicyt™ CE-IVD Edition?

  • Accomplish regulatory requirements in clinical laboratories: IVDD
  • Help with Lab Accreditation (ISO 15189) or other national accrediation programs:
    • CE-IVD: comply with all requirements of Directive 98/79/EC
    • CE-IVD conformity declaration certificate
    • IQ/OQ certificates (also in the RUO version)
    • Logging and security module (also in the RUO version)
      • User access control
      • Audit Trail
      • Password-protected files
      • Electronic signatures

What documentation is available?

You can find additional information about this version and the CE-IVD validation below:

How can I download the new version?

Free download for Infinicyt™ 2.0 users
All Infinicyt™ 2.0 users can go to the Users Area, click on Download 2.0.5 version and select the CE-IVD or the RUO version.

Users of previous Infinicyt™ versions or new users
These users can access to this version through an update or purchase. Get a quote for Infinicyt™ here or contact your Cytognos Sales Representative to get an offer.

Would you like to know more about this version or have a chat with one of our specialists? Get in touch with us.