Press Release
The C. DIFF QUIK CHEK COMPLETE® test from TECHLAB, Inc., part of the SSI Diagnostica Group, receives the first* European IVDR Certification for combined GDH plus Toxin A/B test.
Blacksburg, VA – June 21, 2024 – TECHLAB, Inc., a part of the SSI Diagnostica Group, is pleased to announce that its C. DIFF QUIK CHEK COMPLETE® test has received certification under the European In Vitro Diagnostic Medical Device Regulation (IVDR), a first* for a combined GDH plus toxin A/B test.
The C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay designed for the simultaneous detection of Clostridioides difficile glutamate dehydrogenase (GDH) antigen and toxins A and B in a single reaction well. This innovative test provides both GDH and toxin results within approximately 30 minutes, enabling healthcare professionals to differentiate between active C. difficile infection and colonization in a cost-effective and clinically relevant manner.
“We are proud to achieve IVDR certification for our C. DIFF QUIK CHEK COMPLETE® test,” said Christina Lindved, CEO of SSI Diagnostica Group, “This achievement underscores SSI Diagnostica’s commitment to delivering high-quality diagnostic tools that meet the stringent regulatory requirements and fulfill the needs of healthcare providers and patients worldwide.”
This certification recognizes the test’s adherence to rigorous quality and safety standards, ensuring its reliability and effectiveness in clinical settings across Europe, and marks a significant advancement in SSI Diagnostica’s efforts to enhance diagnostic capabilities for C. difficile infections.
For more information about the C. DIFF QUIK CHEK COMPLETE® test and the TECHLAB portfolio of diagnostic solutions, please visit www.techlab.com. To see the rest of the SSI Diagnostica Group portfolio, please visit www.ssidiagnostica.com.
* This assertion is based on a review of the EUDAMED database, 06/03/2024 at 10:00 am ET USA, which lists IVDR-compliant devices under code W0105011803.
About SSI Diagnostica Group
The SSI Diagnostica Group is a clinical diagnostic company with a mission to help prevent, monitor, and diagnose clinical diseases through quality portfolios of reagents and IVD diagnostic products and solutions. The Group specializes in gastric, respiratory and bloodborne diseases as a leading partner to the IVD and diagnostic industry. The company serves customers globally through its sites in Denmark, the USA, and China. With a long heritage as a leading developer and manufacturer of intestinal diagnostics, TECHLAB, Inc. joined the SSI Diagnostica Group in 2022.
For media inquiries or further information, please contact:
Jodie Lee, M.S., M.B.A.
Director of Marketing
TECHLAB, Inc., a SSI Diagnostica Group company
Email: marketing@techlab.com
Phone: +1 (540) 953-1664