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In Vitro Diagnostic Devices

Known as: In Vitro Diagnostic Device, In Vitro Diagnostic Medical Device, In Vitro Diagnostic Medical Devices 
National Institutes of Health

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Broader (1)

Reagent Kits, Diagnostic

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
Review
2018
Review
2018
Quigley M, Ayihongbe S
Using the metaphor and actuality of the ‘everyday cyborg’, this article makes the case that the law is ill-equipped to deal with… 
2015
2015
News from the Biological Stain Commission, No. 16
Abstract In the 16th issue of News from the Biological Stain Commission (BSC) under the heading of Regulatory affairs, the… 
2013
2013
Assuring the quality of diagnostic tests
How do we know that they do what we think they do? 
2013
2013
About traceability of the biochemical measurement results – some case studies on the metrological and practical aspects
The comparability of biochemical measurement results performed by any medical laboratories could be reached only when common… 
2012
2012
Regulatory approval pathways for molecular diagnostic technology.
This chapter describes the basic categories for regulatory approval to sell/market a molecular profiling technology. The US Food… 
2011
2011
Food and Drug Administration Issues Draft Guidance on In Vitro Diagnostic Devices
O n January 5, 2011, the Food and Drug Administration (FDA) announced the availability of a draft guidance that recommends… 
2006
2006
Wie sicher sind Blutzuckermesssysteme?
ZusammenfassungSeit Implementierung der Richtlinie 98/79/ EG des Europäischen Parlaments und des Rates vom 27. Oktober 1998 über… 
2004
2004
Consumers report glucose meter problems to FDA.
OBJECTIVE Glucose meters have unquestionable clinical utility, particularly in management of diabetes mellitus. U.S. Food and… 
Review
2002
Review
2002
Regulatory issues in tumor marker development.
The Food and Drug Administration (FDA) has been actively involved in oversight of medical devices, including in vitro diagnostic… 
2001
2001
Impact of emerging technologies and regulations on the role of POCT.
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