First Light Diagnostics receives FDA clearance for Clostridiodes difficile test

Aug. 11, 2021

First Light Diagnostics announced that the U.S. Food and Drug Administration (FDA) has cleared its Clostridiodes difficile (C. difficile) test and analyzer to be marketed in the United States.

The SensiTox C. difficile Toxin Test uses single molecule counting to detect toxins and biomarkers. The test detects C. difficile toxins A and B and delivers a result in 35 minutes on the MultiPath Analyzer, a benchtop system with continuous random access loading of specimens.

In addition to its SensiTox C. difficile Toxin Test, First Light is developing a portfolio of products for the rapid generation of antimicrobial susceptibility test (AST) results.

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