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All our Class „A“ products are now IVDR certified as required since May, 2022. Let’s see our offer!
All our Extraction kits and Instruments are now CE IVD certified in compliance with the new Regulation (EU) 2017/746 (IVDR). They meet all requirements for in vitro diagnostic medical devices Class „A“ and it is therefore possible to use them in laboratories for diagnostic purpose.
You can choose from wide range of IVDR products:
Please find new the EU Declaration of Conformity and Instruction for Use in comliance with IVDR requirements on particular product pages.
And why is this certification so important not only for us, but also for all our customers and users of our products? It's a bit tricky – for example, IVDR A products in particular must already be used by laboratories with valid IVDR Certificaton – if not, they run the risk of possible non-compliance. And that's not all. That's why we've put together a series on our social media to debunk the most common myths about IVDR. Keep an eye on our LinkedIN profile to stay up to date so that nothing about IVDR surprises you!
With GeneProof products your laboratory complies with IVDR too!
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GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…