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).