Document Detail


Medical devices; immunology and microbiology devices; classification of Plasmodium species antigen detection assays. Final rule.
MedLine Citation:
PMID:  18605403     Owner:  HSR     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  73     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2008 May 
Date Detail:
Created Date:  2008-07-07     Completed Date:  2008-07-18     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  29052-4     Citation Subset:  T    
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MeSH Terms
Descriptor/Qualifier:
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:
0/Antigens, Protozoan

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