Great Basin Receives 510(k) Clearance for C. difficile MDx Test | GenomeWeb

NEW YORK (GenomeWeb News) – Great Basin today announced it has received 510(k) clearance from the US Food and Drug Administration for its first molecular diagnostic test for Clostridium difficile.

The test is based on a technology that uses an integrated disposable cartridge containing all necessary reagents and runs on a benchtop analyzer. The goal, the Salt Lake City-based firm said, is to deliver assays that can be performed in a CLIA-rated waived or moderately complex laboratory at a lower cost than other molecular diagnostics.

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