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  • Quality controls that are either an integral component or a detachable accessory of in-vitro diagnosis (IVD) test devices. They are used to assess the electronic components and/or a portion of their analytic characteristics (e.g., sample addition, test completion time). These controls may check the device each time a test is performed and provide an alternative to external quality control procedures. Electronic quality controls may be used for IVD test devices of medium or high complexity that are capable of maintaining stable performance specifications over a long period of time.
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