Bio-Techne's Major Certification Success
Bio-Techne Corporation is making waves in the world of medical diagnostics with its recent achievement. The company has successfully completed the Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its R&D Systems Hematology Controls and Calibrators. This significant accomplishment confirms that these products meet stringent quality standards established for in-vitro diagnostic devices.
Importance of IVDR Certification
The IVDR certification is not just a piece of paper; it represents an assurance of quality and reliability. Products certified under the IVDR must adhere to stringent regulations ensuring their accuracy and precision in patient testing. For healthcare professionals, having access to such high-standard controls and calibrators is essential in delivering accurate diagnoses and treatments to patients.
Meeting Healthcare Professionals' Needs
Hematology Controls and Calibrators are vital in laboratory settings. They help ensure that blood tests yield reliable results, directly affecting patient care. With the newly acquired IVDR certification, Bio-Techne has proven its commitment to meeting healthcare professionals' demands for precision in diagnostics. Customers can be assured that they are using top-tier products that contribute to improved patient care.
Commitment to Quality
Dr. Matt McManus, President of Bio-Techne's Diagnostics & Spatial Biology Segment, emphasized the company’s dedication to quality in designing and manufacturing products. He stated, "At Bio-Techne, we take pride in designing and manufacturing products that enable researchers and healthcare professionals to improve patients' lives. We are thrilled to be able to offer IVDR certified Hematology Controls and Calibrators to our customers, ensuring they receive the highest quality products." This passion for excellence is evident in the outcomes that result when partners utilize these cutting-edge tools.
About Bio-Techne Corporation
Established as a global leader in life sciences, Bio-Techne Corporation (NASDAQ: TECH) delivers groundbreaking tools and bioactive reagents for research and clinical diagnostic sectors. The company's extensive range of products supports scientific inquiries into biological mechanisms and the progression of various diseases, enhancing drug discovery initiatives and enabling accurate clinical evaluations. In fiscal 2024, Bio-Techne reported net sales of approximately $1.2 billion and employs around 3,100 dedicated professionals across the world.
Connecting with Bio-Techne
For those interested in learning more about Bio-Techne and its wide array of innovative solutions, the company offers plenty of resources. They maintain a robust online presence, where visitors can explore extensive product offerings. Bio-Techne encourages engagement through various social media platforms, including Facebook, LinkedIn, Twitter, and YouTube, to keep updated with their latest advancements and offerings.
Contact Information
For inquiries regarding investor relations or corporate development, reach out to David Clair, Vice President of Investor Relations & Corporate Development. Contact him via phone at 612-656-4416.
Frequently Asked Questions
What is IVDR certification?
IVDR certification ensures that medical devices meet strict quality and safety standards set by the European Union for in-vitro diagnostic devices.
What products have received the IVDR certification?
Bio-Techne's R&D Systems Hematology Controls and Calibrators have received the IVDR certification.
Why is certification important in healthcare?
Certification is crucial as it ensures that diagnostic products provide accurate, reliable results during patient testing, directly impacting healthcare outcomes.
What does Bio-Techne Corporation specialize in?
Bio-Techne specializes in innovative tools and reagents for life sciences, supporting research and clinical diagnostics across the globe.
How can I contact Bio-Techne for more information?
You can contact Bio-Techne’s investor relations via phone at 612-656-4416 to learn more about their products and services.
