Document Detail

Medical devices; immunology and microbiology devices; classification of AFP-L3% immunological test systems. Final rule.
MedLine Citation:
PMID:  16206426     Owner:  HSR     Status:  MEDLINE    
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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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  70     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2005 Oct 
Date Detail:
Created Date:  2005-10-05     Completed Date:  2005-10-13     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  57748-50     Citation Subset:  T    
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MeSH Terms
Device Approval / legislation & jurisprudence
Equipment Safety / classification,  instrumentation
Immunologic Techniques / classification*,  instrumentation
United States
United States Food and Drug Administration
alpha-Fetoproteins* / chemistry
Reg. No./Substance:

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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