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Are in vitro diagnostic products medical devices?

April 26, 2017Devices diagnostic medical products Vitro

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Are in vitro diagnostic products medical devices?

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Yes. The definition of a “device” includes in vitro diagnostic products – devices that aid in the diagnosis of disease or medical/physiological conditions (e.g., pregnancy) by using human or animal components to cause chemical reactions, fermentation, and the like. A few diagnostic products are intended for use in controlling other regulated products (such as those used to screen the blood supply for transfusion-transmitted diseases) and are regulated as biological products.