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  1. Guidance Documents (Medical Devices and Radiation-Emitting Products)

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

Read the Special Controls Document

Issue Date: 08/27/2015

Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of In Vitro Diagnostics 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).