Document Detail


Introduction to in vitro diagnostic device regulatory requirements.
MedLine Citation:
PMID:  23329438     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
A common application for microfluidics can be found in medical devices where the advantages of small volume measuring equipment can be exploited for In Vitro Diagnostics. This chapter focuses on the US and the EU regulations, explaining the broad landscape and regulatory pathways of each market.
Authors:
Jonathan Day
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Methods in molecular biology (Clifton, N.J.)     Volume:  949     ISSN:  1940-6029     ISO Abbreviation:  Methods Mol. Biol.     Publication Date:  2013  
Date Detail:
Created Date:  2013-01-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9214969     Medline TA:  Methods Mol Biol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  103-12     Citation Subset:  IM    
Affiliation:
DNA Electronics Ltd, Institute of Biomedical Engineering, Imperial College, London, UK, jonathan.day@dnae.co.uk.
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