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ImmunoCard C. difficile GDH

ImmunoCard C. difficile GDH is a rapid qualitative enzyme immunoassay screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens from persons suspected of having C. difficile infection (CDI). This test does not distinguish between toxigenic and non-toxigenic strains of C. difficile. Samples from patients that produce positive results with this test must be further tested with an assay designed to detect toxigenic C. difficile strains and assist with the diagnosis of CDI.

Details

Device typeClostridium difficile antigen IVD, kit, enzyme immunoassay (EIA): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from Clostridium difficile bacteria [e.g., glutamate dehydrogenase antigen (GDA), toxin A and/or toxin B] in a clinical specimen, using an enzyme immunoassay (EIA) method.

FDA categoryAntigen, C. Difficile

Device ID00840733101793

Catalog number716050

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Contact

Phone513-271-3700

Emailinfo@meridianbioscience.com

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