UPDATED: BIO-TECHNE ANNOUNCES IVDR CERTIFIED HEMATOLOGY CONTROLS AND CALIBRATORS
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.
Bio-Techne (NASDAQ: TECH) ha ottenuto la certificazione di Classe B per la Regolamentazione dei Dispositivi Diagnostici In Vitro (IVDR) per i suoi Controlli e Calibratori ematologici R&D Systems, passando dalla precedente classificazione di Classe C. Questa certificazione convalida la conformità alle normative dell'Unione Europea per i dispositivi diagnostici in vitro, confermando gli standard di qualità, accuratezza, precisione e affidabilità dei prodotti. La certificazione rappresenta un traguardo significativo per Bio-Techne nel supportare i professionisti della salute con componenti di test di laboratorio di alta qualità.
Bio-Techne (NASDAQ: TECH) ha logrado la certificación de Clase B para la Regulación de Dispositivos Diagnósticos In Vitro (IVDR) para sus Controles y Calibradores de Hematología de R&D Systems, actualizándose desde la clasificación anterior de Clase C. Esta certificación valida el cumplimiento de las regulaciones de la Unión Europea para dispositivos diagnósticos in vitro, confirmando los estándares de calidad, precisión, exactitud y fiabilidad de los productos. La certificación representa un hito importante para Bio-Techne en el apoyo a los profesionales de la salud con componentes de pruebas de laboratorio de alta calidad.
Bio-Techne (NASDAQ: TECH)는 R&D Systems 혈액학 제어 및 보정기를 위한 체외 진단 기기 규정(IVDR)의 B등급 인증을 획득하였습니다. 이전의 C등급에서 업데이트된 것입니다. 이 인증은 체외 진단 기기에 대한 유럽 연합 규정을 준수함을 검증하며, 제품의 품질 기준, 정확도, 정밀도 및 신뢰성을 확인합니다. 이 인증은 Bio-Techne가 고품질 실험실 테스트 구성 요소를 통해 의료 전문가를 지원하는 데 있어 중요한 이정표를 나타냅니다.
Bio-Techne (NASDAQ: TECH) a obtenu la certification de Classe B pour la Réglementation sur les dispositifs de diagnostic in vitro (IVDR) pour ses contrôles et étalons en hématologie R&D Systems, mise à jour à partir de la classification précédente de Classe C. Cette certification valide la conformité aux réglementations de l'Union Européenne concernant les dispositifs de diagnostic in vitro, confirmant les normes de qualité, d'exactitude, de précision et de fiabilité des produits. La certification représente une étape importante pour Bio-Techne dans le soutien aux professionnels de santé avec des composants de test de laboratoire de haute qualité.
Bio-Techne (NASDAQ: TECH) hat die Klassifizierung B für die Verordnung über In-vitro-Diagnosetests (IVDR) für seine R&D Systems Hämatologie-Kontrollen und -Kalibrierungen erreicht, und damit von der vorherigen Klassifizierung C aktualisiert. Diese Zertifizierung bestätigt die Einhaltung der Vorschriften der Europäischen Union für In-vitro-Diagnosetechnologien und bekräftigt die Qualitätsstandards, Genauigkeit, Präzision und Zuverlässigkeit der Produkte. Die Zertifizierung stellt einen bedeutenden Meilenstein für Bio-Techne dar, um Fachkräfte im Gesundheitswesen mit hochwertigen Komponenten für Labortests zu unterstützen.
- Achieved EU IVDR certification for Hematology Controls and Calibrators
- Upgraded from Class C to Class B classification
- Enhanced market access in the European Union
- None.
Insights
The IVDR Class B certification for Bio-Techne's hematology controls and calibrators represents a significant regulatory milestone in the EU market. This certification, which was updated from Class C to Class B, indicates a lower risk classification while maintaining stringent quality standards. The development strengthens Bio-Techne's position in the
The certification ensures continued market access in the EU, where regulatory requirements have become more stringent under IVDR compared to the previous IVD Directive. This compliance demonstrates the product line's reliability and could potentially lead to increased market share in European laboratories. The timing is strategic, as many companies are still struggling to meet IVDR requirements before the 2025-2026 deadlines.
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.
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
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