MagSi-DX Pathogen declared to meet IVDR
The In Vitro Diagnostics Regulation (IVDR) is the new regulatory framework which will affect all in vitro diagnostic medical devices on the European market. The IVDR (Regulation (EU) 2017/746) replaces the EU Directive on in vitro diagnostic devices (IVDD 98/79/EC) and will apply from 26 May 2022 onward.
Our product MagSi-DX Pathogen (to be used for the isolation and purification of viral RNA for subsequent in-vitro diagnostic purposes) has been declared to meet the IVDR requirements and, subsequently, has been registered at the official government body.
We will continue marketing MagSi-DX Pathogen and other clinical diagnostic extraction products, compliant with the new regulations.
We congratulate everyone in and outside of magtivio who made this IVDR compliance possible.
Since July 6, 2021 magtivio is ISO 9001:2015 certified. The scope of this certification is the design, development, manufacture and distribution of magnetic separation solutions for the pre-treatment of body fluids in R & D. The certification has been granted by TÜV Rheinland until 2024.
magtivio has assumed a pro-active policy on employee’s health since the start of the Covid-19 pandemic. All of our people are donating a saliva sample twice a week which is then tested on Covid-19 by PCR. Besides our in-house, protective measures that are in place in this way we protect our personnel and keep our business going.
Repetitive saliva testing can help identify people who spread the virus but don’t show any symptoms. The technique is therefore complementary to existing testing strategies and can be used as a third wall of defense to keep companies and organizations open. Saliva sampling is non-invasive and not as unpleasant or painful as e.g. nasopharyngeal swabs. It allows for easy sampling and there is no need for medical or trained staff.
For RNA extraction from these saliva samples we use our magtivio MagSi-NA Pathogens kit. This kit is already used for RNA extraction from 10s of millions of samples in advance of PCR or LAMP analysis in many Covid-19 testing laboratories in Europe.
The PCR is done by the biosellal Bio-T kit® SARS-CoV-2 UK & N501Y Variants, or by the Kylt® SARS-CoV-2 Complete RTU (CE IVD marked human diagnostic kit) from Anicon.
More information about the effectiveness of saliva testing can be found in the whitepaper from biogazelle, a Ghent (B) – based CRO.
We are actively looking for new distribution partners for our magnetic separation solutions.
Please contact us for the options of selling branded magtivio products, especially when you’re based in Latin-America, Eastern Europe and Scandinavia.
Let us know if you are interested to become a new magtivio partner.