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Techlab Gets IVDR Certification for C. Difficile Test

NEW YORK — Techlab said last week that it has received European In Vitro Diagnostic Medical Device Regulation (IVDR) certification for its C. Diff Quik Chek Complete test.

The test is a rapid membrane enzyme immunoassay designed for the simultaneous detection of Clostridioides difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well, providing results within 30 minutes.

According to Blacksburg, Virginia-based Techlab, which is part of Denmark's SSI Diagnostica, the test can help clinicians differentiate between active C. difficile infection and colonization.