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News 2022-08-15

IVDR-registration of the Class A products part of QuickMIC

Today we announce that we have registered QuickMIC® instrument and sample preparation kit as IVDR Class A. This implicates that our diagnostic system now fulfills the new regulatory requirements and transition provision for the European market. Following clinical performance evaluation, all devices in the QuickMIC system were CE-IVD marked earlier in 2022, indicating IVDD compliance.

Link to the press release

Gradientech is an ISO13485 certified company since 2017

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Gradientech AB
Uppsala Science Park
SE-751 83 Uppsala
Sweden

sales@gradientech.se

About Gradientech

Gradientech develops, manufactures and sells innovative microfluidic products for high-quality analysis of the behavior of cells and organisms in response to gradients of biomolecules. Our aim is to pioneer life science and healthcare.

Copyright © 2024 Gradientech. All rights reserved. Gradientech, QuickMIC and CellDirector are registered trademarks or trademarks of Gradientech AB.

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