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C. DIFFICILE TOX-B TEST

The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with patient history.

Details

Device typeClostridium difficile antigen IVD, kit, cell culture assay: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative measurement of the cytotoxicity of antigens to Clostridium difficile bacteria [e.g., toxin A and/or toxin B] in a clinical specimen, using a cell culture assay.

FDA categoryReagents, Clostridium Difficile Toxin

Device ID00857031002264

AvailabilityPrescription

Single useYes

MRI safetyLabeling does not contain MRI Safety Information

Contact

No contact is listed for this device.

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