No image

C. DIFFICILE TOX A/B II

The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.

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 categoryReagents, Clostridium Difficile Toxin

Device ID00857031002424

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Contact

No contact is listed for this device.

Related products

Product	Model	Company	Device type
C. DIFFICILE TOX-B TESTTechlab, Inc.Clostridium difficile antigen IVD, kit, cell culture assay	T5003	Techlab, Inc.	Clostridium difficile antigen IVD, kit, cell culture assay
PREMIER C. difficile GDHMeridian Bioscience, Inc.Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)	611096	Meridian Bioscience, Inc.	Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
ImmunoCard C. difficile GDHMeridian Bioscience, Inc.Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)	716050	Meridian Bioscience, Inc.	Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
C. DIFF CHEK - 60Techlab, Inc.Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)	30392	Techlab, Inc.	Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)