Analytical Studies: The statements and descriptions in the following sections refer to all in vitro diagnostic medical devices. It must be noted however that there are applicability differences between instrumentation and reagent-based assays, and that the assays themselves may be quantitative, semi-quantitative or qualitative in nature. There may be limited applicability of some of the following sub-sections for qualitative or semi-quantitative assays. Where possible, comments regarding instrumentation or qualitative assays appear in the sub-sections.