; (ii) providing information for diagnosing, screening, measuring, detecting, predicting, prognosing, analyzing, or monitoring a disease or condition, including by making a determination of an individual’s state of health; or (iii) selecting, monitoring, or informing therapy or treatment for a disease or condition; and (B) may include— (i) a test protocol or laboratory test protocol; (ii) an instrument (as defined in section 587(11)); (iii) an article for taking, deriving, holding, or transporting specimens from the human body (as defined in section 587(16)); (iv) software, excluding software that is excluded by section 520(o) from the definition of a device under section 201(h), and excluding modifications that are exempt in accordance with section 587A(l)(2)(A)