| Medical devices; immunology and microbiology devices; classification of quality control material for cystic fibrosis nucleic acid assays. Final rule. | |
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MedLine Citation:
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PMID: 17294552 Owner: HSR Status: MEDLINE |
Abstract/OtherAbstract:
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The Food and Drug Administration (FDA) is classifying quality control material for cystic fibrosis nucleic acid 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: Quality Control Material for Cystic Fibrosis Nucleic Acid 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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Authors:
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Federal register Volume: 72 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 2007 Jan |
Date Detail:
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Created Date: 2007-02-12 Completed Date: 2007-03-05 Revised Date: 2009-11-19 |
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: 1174-6 Citation Subset: T |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Cystic Fibrosis
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diagnosis*,
immunology Device Approval Genetic Testing / legislation & jurisprudence* Humans Immunoassay / classification* Nucleic Acids / diagnostic use* Quality Control Reproducibility of Results United States United States Food and Drug Administration |
| Chemical | |
Reg. No./Substance:
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0/Nucleic Acids |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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