; (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); and (v) subject to subparagraph (2), a component or part of a test, a test protocol, an instrument, an article, or software described in any of clauses (A) through (D) of such subparagraph, whether alone or in combination, including reagents, calibrators, and controls. (2) Notwithstanding subparagraph (1)(v), an article intended to be used as a component or part of an in vitro clinical test described in subparagraph (1) is excluded from the definition in subparagraph (1) if the article consists of any of the following: (A) Blood, blood components, or human cells or tissues, from the time of acquisition, donation, or recovery of such article, including determination of donor eligibility, as applicable, until such time as the article is released as a component or part of an in vitro clinical test by the establishment that collected such article. (B) An article used for invasive sampling, a needle, or a lancet, except to the extent such article, needle, or lancet is an integral component of an article for holding, storing, or transporting a specimen. (C) General purpose laboratory equipment, including certain pre-analytical equipment, as determined by the Secretary. (D) An article used solely for personal protection during the administering, conducting, or otherwise performing of test activities. ; (2) by adding at the end of section 201(g) the following: (3) The term drug does not include an in vitro clinical test. ; and (3) in section 201(h), by striking section 520(o) and inserting section 520(o) or an in vitro clinical test . (b) Exclusion from definition of biological product Section 351(i)(1) of the Public Health Service Act ( 42 U.S.C. 262(i)(1) ) is amended— (1) by striking (1) The term biological product means and inserting (1)(A) The term biological product means