PRODUCTS CONTACT COMPANY EVENTS ACADEMY NEWS In Vitro Diagnostic Medical Devices Regulation Home/In Vitro Diagnostic Medical Devices Regulation In Vitro Diagnostic Medical Devices Regulation EU 2017/746 In May 2017, the European Union published the In Vitro Diagnostic Medical Devices Regulation EU 2017/746 (IVDR) which repeals the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) in order to establish a more robust, transparent, predictable and suitable regulatory framework for IVD Medical Devices. Consult here all information related to IVDR Cytognos and the new IVD Regulation Cytognos offers extensively validated panels. In order to guarantee the quality and the availability of our products, we are working hard to continue offering our diagnostic kits, antibodies, Infinicyt™ and Omnicyt™ under the IVDR (the end of the transition period to implement the new Regulation is on May 26th, 2022). If the transition period does not allow us to have any of the above products on the market as CE-IVD (under the new Regulation by the specified date), then we will follow the indications established in the Article 110 (4) of the IVDR. This means that these products will be available as CE-IVD until May 27th 2025 or the expiration date, whatever occurs first, until an IVDR certificate is issued. CYTOGNOS CE-IVD PRODUCT LIST Our products Next Generation Flow Solutions Acute Leukemia Chronic Lymphoproliferative Disorders Plasma Cell Dyscrasias Primary Immunodeficiencies Omnicyt™ Infinicyt™ The company About us Contact & Support Events Work with us Projects Subscribe to Newsletter Useful information EuroFlow™ Cytognos technology Minimal Residual Disease Clinical trials Scheduled webinars FAQs Legal Notice Legal Notice Terms of use Privacy Policy Cookie Policy Terms and Conditions of Sale Anti-corruption Policy License Agreement Cytognos, S.L. complies with ISO 9001:2015 Quality Management and ISO 13485:2016 for the design, development, production and sale of antibodies and flow cytometry kits for In Vitro products and research. Cytognos, S.L. products for In Vitro Diagnostic comply with Directive 98/79/EC. Copyright © 2021 Cytognos S.L.. All Rights Reserved. All products listed are labeled with some regulatory status as per indicated below: “RUO” or “For Research Use Only”: not intended for diagnostic or therapeutic procedures. “CE-IVD”: products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). “LUO” or “Laboratory Use Only”: general purpose laboratory reagents. “ASR” or “Analyte Specific Reagent”: reagents in which the analytical and performance characteristics are not established. ASRs are regulated by the US Food and Drug Administration (FDA). Cookies We use cookies to improve our website and your experience when using it. Cookies used for the essential operation of the site have already been set. To find out more about the cookies we use and how to delete, please read more. Accept Read more Change Settings