federal_register: 2014-21479

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-21479 Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Nucleic Acid Amplification Test Reagents Rule The Food and Drug Administration (FDA) is classifying dengue virus nucleic acid amplification test reagents into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device. 2014-09-10 2014 9 https://www.federalregister.gov/documents/2014/09/10/2014-21479/medical-devices-immunology-and-microbiology-devices-classification-of-dengue-virus-nucleic-acid https://www.govinfo.gov/content/pkg/FR-2014-09-10/pdf/2014-21479.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying dengue virus nucleic acid amplification test reagents into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to...

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