| Medical devices; immunology and microbiology devices; classification of Plasmodium species antigen detection assays. Final rule. | |
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MedLine Citation:
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PMID: 18605403 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is classifying Plasmodium species antigen detection assays into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays." 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. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device. |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 73 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2008 May |
Date Detail:
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Created Date: 2008-07-07 Completed Date: 2008-07-18 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: 29052-4 Citation Subset: T |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Antigens, Protozoan / blood* Humans Immunologic Tests / classification*, instrumentation Microbiological Techniques / classification* Plasmodium / immunology*, microbiology United States United States Food and Drug Administration |
| Chemical | |
Reg. No./Substance:
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0/Antigens, Protozoan |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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