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Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene Amplification Assay. Final order.

出版信息

Fed Regist. 2015 Aug 27;80(166):51938-9.

PMID:26314093
Abstract

The Food and Drug Administration (FDA) is classifying Clostridium difficile (C. difficile) toxin gene amplification assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

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