| Medical devices; immunology and microbiology devices; classification of norovirus serological reagents. Final rule. | |
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MedLine Citation:
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PMID: 22420063 Owner: HSR Status: In-Process |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is classifying norovirus serological reagents into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Class II Special Controls Guidance Document: Norovirus Serological Reagents.'' The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls. |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 77 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2012 Mar |
Date Detail:
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Created Date: 2012-03-15 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: United States |
Other Details:
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Languages: eng Pagination: 14272-4 Citation Subset: T |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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