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In vitro diagnostic tests
are medical device
A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery . Whereas medicinal products achieve their principal action by pharmacological, metabolic or immunological means. Medical devices act by other means like physical, mechanical, thermal,...
s intended to perform diagnoses from assays in a test tube
A test tube, also known as a culture tube or sample tube, is a common piece of laboratory glassware consisting of a finger-like length of glass or clear plastic tubing, open at the top, usually with a rounded U-shaped bottom....
, or more generally in a controlled environment outside a living organism. In vitro
In vitro refers to studies in experimental biology that are conducted using components of an organism that have been isolated from their usual biological context in order to permit a more detailed or more convenient analysis than can be done with whole organisms. Colloquially, these experiments...
means in glass
A 'in vitro diagnostic medical device' is, according to the directive
Directive may refer to:* Directive , a legislative act of the European Union* Directive , a highly-acclaimed poem by Robert Frost...
Common tests include blood tests for glucose, liver enzymes, levels of electrolytes such as calcium, sodium, and potassium, and tests for drugs.
Purposes of testing include protecting the blood supply, monitoring the levels of drugs given and providing information to assist in the diagnosis and treatment of disease. These tests are generally run in hospital pathology laboratories and can in specific instances also be carried out in doctors’ surgeries, in high street pharmacies or by patients themselves.