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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
원저 : 국내 동물용 의료기기 관리실태 평가 및 개선방안 연구
In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and… 
2014
2014
Rechtsgrundlagen und Praxis bei der Prüfung von kritischen In-vitro-Diagnostika
ZusammenfassungIn-vitro-Diagnostika (IVD) werden in verschiedene Risikoklassen eingeteilt, abhängig von den möglichen… 
Review
2014
Review
2014
The Current State of the U.S. Food and Drug Administration Process and Regulations for Diagnostic Laboratory Assays
The United States (US) Food and Drug Administration (FDA) regulates the sale and distribution of in vitro diagnostic devices… 
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
Vigilance system for medical devices: the experience of an Italian hospital
Background The pharmacovigilance on Medical Devices (MDs) and In Vitro Diagnostic Medical Devices (IVDs) represents a relevant… 
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Food and Drug Administration Issues Draft Guidance on In Vitro Diagnostic Devices
O n January 5, 2011, the Food and Drug Administration (FDA) announced the availability of a draft guidance that recommends… 
2008
2008
Wie sicher sind Testsysteme zur Diagnostik von Infektionskrankheiten?
ZusammenfassungDie europäische Richtlinie 98/79/EG über In-vitro-Diagnostika (IVD) regelt das Inverkehrbringen und die Markt… 
2006
2006
Wie sicher sind Blutzuckermesssysteme?
ZusammenfassungSeit Implementierung der Richtlinie 98/79/ EG des Europäischen Parlaments und des Rates vom 27. Oktober 1998 über… 
2002
2002
Role of the U.S. Food and Drug Administration in Regulation of Commercial Clinical Microbiology Products
As the U.S. Food and Drug Administration (FDA) approval process has a major impact on how and when new in vitro diagnostic… 
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