UPDATED: BIO-TECHNE ANNOUNCES IVDR CERTIFIED HEMATOLOGY CONTROLS AND CALIBRATORS

Rhea-AI Summary

Bio-Techne (NASDAQ: TECH) has achieved Class B In Vitro Diagnostic Regulation (IVDR) certification for its R&D Systems Hematology Controls and Calibrators, updating from the prior Class C classification. This certification validates compliance with European Union regulations for in-vitro diagnostic devices, confirming the products' quality standards, accuracy, precision, and reliability. The certification represents a significant milestone for Bio-Techne in supporting healthcare professionals with high-quality laboratory testing components.

Positive

• Achieved EU IVDR certification for Hematology Controls and Calibrators
• Upgraded from Class C to Class B classification
• Enhanced market access in the European Union

Negative

• None.

R&D Systems Hematology Controls and Calibrators has completed the Class B Certification under the new European Union In Vitro Diagnostic Regulation

This press release updates the IVDR Classification to Class B from the prior Class C. 

MINNEAPOLIS, Nov. 11, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) has recently achieved In Vitro Diagnostic Regulation (IVDR) certification for its R&D Systems Hematology Controls and Calibrators. This certification confirms that the products comply with the regulations and guidelines set forth by the European Union for in-vitro diagnostic devices.

This IVDR certification demonstrates the product's exceptional quality standards, ensuring high levels of accuracy, precision, and reliability. It marks an important milestone in Bio-Techne's commitment to meeting the needs of healthcare professionals.

Hematology Controls and Calibrators are essential components in the laboratory setting that support accuracy in patient testing. With the IVDR certification, customers can be assured that Bio-Techne's R&D Systems Hematology Controls and Calibrators meet the rigorous standards required in hematology.

"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," said Dr. Matt McManus, President of Bio-Techne's Diagnostics & Spatial Biology Segment.

About Bio-Techne Corporation
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex® Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing.

For more information on Bio-Techne and its brands, please visit https://www.bio- techne.com or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube.

Contact: David Clair, Vice President, Investor Relations & Corporate Development
david.clair@bio-techne.com
612-656-4416

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SOURCE Bio-Techne Corporation

FAQ

What IVDR certification did Bio-Techne (TECH) receive in November 2024?

Bio-Techne received Class B IVDR certification for its R&D Systems Hematology Controls and Calibrators, upgrading from the prior Class C classification.

How does the IVDR certification benefit Bio-Techne's (TECH) products?

The IVDR certification validates that Bio-Techne's Hematology Controls and Calibrators meet European Union quality standards for accuracy, precision, and reliability in in-vitro diagnostic devices.

What products received Bio-Techne's (TECH) IVDR certification in 2024?

Bio-Techne's R&D Systems Hematology Controls and Calibrators received the IVDR Class B certification.