federal_register: 2015-21237

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-21237 Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene Amplification Assay Rule 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. 2015-08-27 2015 8 https://www.federalregister.gov/documents/2015/08/27/2015-21237/medical-devices-immunology-and-microbiology-devices-classification-of-clostridium-difficile-toxin https://www.govinfo.gov/content/pkg/FR-2015-08-27/pdf/2015-21237.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...  

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