The last step of the IVDR implementation completed
The Gentian Cystatin C and GCAL® assays have been IVDR certified by TüV SÜD since September 2022. Gentian has now fully implemented IVDR with the final steps of updating the products' labels and documents completed March 1st 2023.
We are excited and proud to have now completed the last step of the IVDR implementation! It has been a project lasting for more than 3 years, and this important milestone is a result of great collaboration across departments and very dedicated employees.
Anne-Mette Akre, VP Quality Assurance and Regulatory Affairs
Gentian started to prepare for implementation of the European In-Vitro Diagnostic Regulation, EU 2017/746 in 2017, to ensure continuous compliance for existing and pipeline products.
Explore the assays in your lab
The Gentian Cystatin C Immunoassay and GCAL®, the Gentian Calprotectin Immunoassay for plasma and serum, are both open channel turbidimetric assays available for use on most major clinical chemistry platforms currently on the market.
These newly IVDR-certified products with Gentian’s robust manufacturing capabilities offer a very attractive solution for laboratory end-users, distributors and OEM-partners.
The products are available as:
- Ready to use kits for laboratory testing
- Bulk supply
- Tailor-made packaging
- Private label
Get in touch for more information and validation opportunities
Are you interested in adding our assays to your test menu, distributing our products or to discuss OEM opportunities for your company? Partner with us for high quality, security of supply, customisation and expertise.
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