CATEGORIES OF SERIOUS HEALTH CONDITIONS
Note: The term “device registry” as used here should not be confused with the concept of device registration and listing. (See GHTF SG1N065) GHTF/SG5/N4:2010 Diagnostic sensitivity (Clinical sensitivity): Ability of an IVD medical device to identify the presence of a target marker associated with a particular disease or condition. NOTE 1: ................
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