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In Vitro Diagnostics (IVD)

21:06 EDT 21st September 2017 | BioPortfolio

In vitro diagnostics are tests that can detect diseases, conditions, or infections. Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home.

What is an in vitro diagnostic medical device (IVD)?

Broadly, a device is an IVD when the manufacturer has intended its use for the in vitro diagnostic examination of specimens derived from the human body. IVDs can include:

  • blood glucose meters, home pregnancy tests, test kits used in hospital laboratories
  • reagents, calibrators and control materials, whether supplied alone or as part of a kit
  • analyser systems, analytical instruments, apparatus or equipment
  • Point of Care testing and self-testing devices
  • specimen receptacles (including blood collection tubes) specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro examination
  • accessories to IVD devices. These are 'intended specifically by the manufacturer to be used together with an IVD to enable that IVD to be used in accordance with its intended purpose'. A multi-well tile on which immunoassays are performed would therefore be an IVD accessory, while a volumetric flask would be general laboratory equipment

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