In vitro diagnostic medical device: Difference between revisions
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{{MitoPedia | {{MitoPedia | ||
|abbr=IVD | |abbr=IVD | ||
|description=A [[medical device]] is an | |description=A [[medical device]] is an '''in vitro diagnostic medical device (IVD)''' if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use. | ||
|info=https://www.tga.gov.au/ivd-medical-devices-definitions-links | |info=https://www.tga.gov.au/ivd-medical-devices-definitions-links | ||
}} | }} | ||
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|mitopedia concept=MitoFit Quality Control System | |mitopedia concept=MitoFit Quality Control System | ||
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:::: It must be intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient, or to monitor therapeutic measures. | |||
It must be intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient, or to monitor therapeutic measures. | |||
The definition of an IVD does not encompass products that are intended for general laboratory use that are not manufactured, sold or presented for use specifically as an IVD. | :::: The definition of an IVD does not encompass products that are intended for general laboratory use that are not manufactured, sold or presented for use specifically as an IVD. | ||
:::: '''Classification''' of IVDs describes the category to which an IVD belongs: http://www.ce-marking.com/medical-devices.html#whichclassification | |||
Revision as of 13:39, 23 February 2020
- high-resolution terminology - matching measurements at high-resolution
In vitro diagnostic medical device
Description
A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.
Abbreviation: IVD
Reference: https://www.tga.gov.au/ivd-medical-devices-definitions-links
MitoPedia concepts: "MitoFit Quality Control System" is not in the list (MiP concept, Respiratory state, Respiratory control ratio, SUIT concept, SUIT protocol, SUIT A, SUIT B, SUIT C, SUIT state, Recommended, ...) of allowed values for the "MitoPedia concept" property.
MitoFit Quality Control System"MitoFit Quality Control System" is not in the list (Enzyme, Medium, Inhibitor, Substrate and metabolite, Uncoupler, Sample preparation, Permeabilization agent, EAGLE, MitoGlobal Organizations, MitoGlobal Centres, ...) of allowed values for the "MitoPedia topic" property.
- It must be intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, solely or principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient, or to monitor therapeutic measures.
- The definition of an IVD does not encompass products that are intended for general laboratory use that are not manufactured, sold or presented for use specifically as an IVD.
- Classification of IVDs describes the category to which an IVD belongs: http://www.ce-marking.com/medical-devices.html#whichclassification
