Open for clinical study and research applications: LinkGut, Now with IVDR and CE Certification
2 min read
Carbiotix recently announced a significant milestone in the development and distribution of its LinkGut testing kit by achieving In Vitro Diagnostic Regulation (IVDR) Class A and CE marked status. This achievement represents a crucial step forward for the company, affirming the reliability, safety, and compliance of the LinkGut testing kit with European Union standards. The IVDR is a stringent regulatory framework designed to ensure the safety and performance of in vitro diagnostic devices within the EU. By complying with these regulations, Carbiotix ensures that its LinkGut testing kit meets high-quality standards, providing accurate and reliable results for microbiome health diagnostics.
The CE mark further signifies that the product can be freely marketed across the European Economic Area, opening up a vast market for Carbiotix. This status not only enhances the company's credibility but also increases the trust among consumers, businesses, researchers, and healthcare professionals in the effectiveness and safety of their product. It enables Carbiotix to stand out in the competitive microbiome industry, where reliable and validated diagnostic tools are essential for advancing personalized nutrition and microbiome health.
For Carbiotix, achieving IVDR and CE marked status for the LinkGut testing kit is more than just a regulatory accomplishment; it represents an opportunity to lead in the innovation of microbiome health diagnostics, fully levergaing the cost-advantages, flexibility and reliability of the LinkGut service for clinical and research applications. It allows the company to expand its reach across Europe, providing individuals, businesses, researchers and health care professionals with the tools they need to monitor and improve microbiome health effectively. This milestone also positions Carbiotix to further its research and development efforts, leveraging the validation and credibility gained to foster partnerships, enhance product offerings, and ultimately contribute to the broader understanding and importance of microbiome health in overall well-being.
Contact us at info@carbiotix.com to find out more about Carbiotix, our clinical study, research and B2B LinkGut testing service.