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SPECIAL CONTROLS DOCUMENT

Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile Guideline for Industry and Food and Drug Administration Staff August 2015

Final

Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile

Docket Number:
FDA-2015-N-2963
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This special controls guideline was developed to support the classification of a Clostridium difficile toxin gene amplification assay into class II (special controls).


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