Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests
Description:
In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or tissue, to provide information in making health care decisions. Examples of IVDs include pregnancy test kits or blood glucose tests for home use; laboratory tests for infectious disease, such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and tests for various genetic diseases or conditions. More recently, a specific type of diagnostic test--called a companion diagnostic-…
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Date:
March 27, 2014
Creator:
Sarata, Amanda K.
Item Type:
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Partner:
UNT Libraries Government Documents Department