“In-vitro diagnostic medical device” means ‘any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body
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Anticoagulants are used to prevent clot formation both in vitro and in vivo. In the specific field of in vitro diagnostics, anticoagulants are commonly added to collection tubes either to maintain blood in the fluid state for hematological testing or to obtain suitable plasma for coagulation and cli …
specifications for in vitro diagnostics (IVDs) constitute a set of predefined criteria and baseline requirements to ensure good quality, safety, performance and efficacy. The specifications are decisive companions to the WHO Mod - el List of Essential In Vitro Diagnostics (EDL) that will allow Member States, donor agencies and nongovern-
In vitro diagnostic medical devices: procurement, safety, quality and performance; In vitro diagnostic point-of-care test devices; Virtual manufacturing of medical devices; Medical devices: off
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 (1) pregnancy test kits or blood glucose tests for home use; (2) laboratory tests for infectious disease,
The high demand for in vitro diagnostics could seed structural shifts that will have long-term implications for diagnostic-test manufacturers. (6 pages) With high technological and regulatory barriers to entry, in vitro diagnostics (IVD) has been a relatively high-margin industry, with molecular diag­nostics being one of its fastest-growing
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how to use in vitro diagnostic test