FDA Approves Great Basin’s Pathogen Assay
Great Basin received 510(k) clearance for its stool bacterial pathogens panel for gastrointestinal distress.
The assay detects pathogens including Shigella, E. coli, Campylobacter and Salmonella.
More than 40 labs or hospitals are evaluating or plan to evaluate the panel, and those that have already evaluated it can now adopt the device.
With the approval secured, the company plans to market the panel to more than 200 additional sites.