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This microwell enzyme-linked immunoabsorbant assay (ELISA) detection kit (C. difficile Toxin A+B ELISA Kit) is an in vitro diagnostic (IVD) immunoassay intended for use as an aid in the diagnosis of C. difficile associated disease. The kit detects C. difficile toxin A and B in human feces using peroxidase as the indicator enzyme. The assay may be read visually or with an ELISA reader. This IVD C. difficile Toxin A+B ELISA Kit is intended to be used with human stools that are fresh, frozen or in Cary Blair transport media in a clinical laboratory use setting. The kit may also be used with IVD Research's Quick'N'Easy fecal dilution device.

C. difficile Toxin A+B Fecal Antigen Detection Microwell ELISA

The provided text is a 510(k) premarket notification letter from the FDA to IVD Research Inc. for their C. difficile Toxin A+B Fecal Antigen Detection Microwell ELISA. It primarily concerns the FDA's determination of substantial equivalence and does not contain detailed information about the acceptance criteria, study design, or performance metrics of the device as requested. The document confirms that the device is cleared for marketing but does not provide the underlying study data to support that clearance.

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