| Medical devices; immunology and microbiology devices; classification of AFP-L3% immunological test systems. Final rule. | |
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MedLine Citation:
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PMID: 16206426 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is classifying AFP-L3% (alpha-fetoprotein L3 subfraction) immunological test systems 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: AFP-L3% Immunological Test Systems." 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 a guidance document that will serve as the special control for the device. |
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Authors:
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 70 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2005 Oct |
Date Detail:
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Created Date: 2005-10-05 Completed Date: 2005-10-13 Revised Date: 2006-11-15 |
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: 57748-50 Citation Subset: T |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Device Approval
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legislation & jurisprudence Equipment Safety / classification, instrumentation Humans Immunologic Techniques / classification*, instrumentation United States United States Food and Drug Administration alpha-Fetoproteins* / chemistry |
| Chemical | |
Reg. No./Substance:
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0/alpha-Fetoproteins |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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