BIO-TECHNE ANNOUNCES IVDR CERTIFIED HEMATOLOGY CONTROLS AND CALIBRATORS

Rhea-AI Summary

Bio-Techne (NASDAQ: TECH) has achieved IVDR certification for its R&D Systems Hematology Controls and Calibrators, confirming compliance with European Union regulations for in-vitro diagnostic devices. This certification underscores the products' high quality, accuracy, precision, and reliability. It represents a significant milestone in Bio-Techne's dedication to supporting healthcare professionals with top-tier laboratory components. The certified Hematology Controls and Calibrators are vital for ensuring accurate patient testing in laboratories, meeting stringent hematology standards.

Positive

• Achieved IVDR certification for Hematology Controls and Calibrators.
• Compliance with European Union regulations for in-vitro diagnostic devices.
• Enhanced product quality, accuracy, precision, and reliability.

Negative

• None.

Insights

Medical Research Analyst

The IVDR certification for Bio-Techne's hematology controls represents a significant regulatory milestone that strengthens the company's position in the European diagnostics market. This Class C certification, which is among the higher risk classifications under IVDR, validates the product's quality and reliability for clinical laboratories.

The certification timing is strategic, as laboratories across Europe are transitioning to meet stricter IVDR requirements. This early compliance gives Bio-Techne a competitive advantage in the $7.6 billion global hematology controls market. The certification will likely drive increased market penetration in Europe and potentially boost market share, as non-certified products will be gradually phased out of the market.

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

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 products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $1.2 billion in net sales in fiscal 2024 and has approximately 3,100 employees worldwide. 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 certification did Bio-Techne's Hematology Controls and Calibrators achieve?

Bio-Techne's Hematology Controls and Calibrators achieved IVDR certification.

What does IVDR certification mean for Bio-Techne's products?

IVDR certification confirms that Bio-Techne's products comply with European Union regulations for in-vitro diagnostic devices, ensuring high quality, accuracy, precision, and reliability.

Why is the IVDR certification important for Bio-Techne's Hematology Controls and Calibrators?

The IVDR certification is important because it assures customers that Bio-Techne's Hematology Controls and Calibrators meet rigorous hematology standards, supporting accurate patient testing.

How does the IVDR certification impact Bio-Techne's commitment to healthcare professionals?

The IVDR certification demonstrates Bio-Techne's commitment to providing high-quality products that meet the needs of healthcare professionals by ensuring accuracy and reliability in laboratory testing.