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Food and Drug Administration Regulation of in Vitro Diagnostic Devices

The Food and Drug Administration regulates the sale and distribution of laboratory devices under a statutory and regulatory framework that is unfamiliar to most clinical laboratory scientists. In this article we briefly describe the criteria that are used to classify and review in vitro diagnostic d...

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Detalhes bibliográficos
Main Authors: Mansfield, Elizabeth, O’Leary, Timothy J., Gutman, Steven I.
Formato: Artigo
Idioma:Inglês
Publicado em: American Society for Investigative Pathology 2005
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC1876654/
https://ncbi.nlm.nih.gov/pubmed/15681468
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