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Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197?

Recently, the Food and Drug Administration (FDA) published guidance documents for point-of-care testing (POCT) and over-the-counter (OTC) blood glucose monitoring systems (BGMS). These are expected to improve weaknesses of the already established ISO 15197:2013 standard accuracy evaluation for OTC B...

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Detalhes bibliográficos
Publicado no:J Diabetes Sci Technol
Main Authors: Freckmann, Guido, Baumstark, Annette, Pleus, Stefan
Formato: Artigo
Idioma:Inglês
Publicado em: SAGE Publications 2017
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5951049/
https://ncbi.nlm.nih.gov/pubmed/28587476
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1932296817713220
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