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UPDATED: BIO-TECHNE ANNOUNCES IVDR CERTIFIED HEMATOLOGY CONTROLS AND CALIBRATORS Bio-Techne Corporation (NASDAQ: TECH) has recently achieved In Vitro Diagnostic Regulation (IVDR) certification for its R&D Systems Hematology...

Key Takeaway: Bio-Techne Corporation has successfully achieved In Vitro Diagnostic Regulation (IVDR) certification for its R&D Systems Hematology Controls and Calibrators, upgrading its classification from Class C to Class B. This certification ensures that their products meet stringent EU regulations for in-vitro diagnostic devices. The company emphasizes its commitment to providing high-quality products that improve patient testing accuracy in laboratory settings. Dr. Matt McManus, the President of Bio-Techne's Diagnostics & Spatial Biology Segment, expressed excitement about offering certified products to healthcare professionals.
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POSITIVE FACTORS

  • Achieved IVDR certification for hematology controls and calibrators.
  • Assures customers of compliance with EU regulations for in-vitro diagnostic devices.
  • Enhances accuracy in patient testing, benefiting healthcare professionals.

Full Press Release Details

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.
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 .

Frequently Asked Questions

What is the recent certification achieved by Bio-Techne?

Bio-Techne achieved Class B Certification for its Hematology Controls and Calibrators.

What does Class B certification signify?

Class B certification indicates compliance with the European Union's IVDR for diagnostics.

Why are Hematology Controls and Calibrators important?

They ensure testing accuracy in laboratory settings for patient diagnostics.

Who is the president of Bio-Techne's Diagnostics segment?

Dr. Matt McManus is the president of Bio-Techne's Diagnostics & Spatial Biology Segment.

Where can I find more information about Bio-Techne?

Visit https://www.bio-techne.com for more information about Bio-Techne.

Last updated: Nov 11, 2024