; and (ii) does not analyze, process, or interpret a signal, pattern, or medical image from a device; and (G) subject to subparagraph (3), a component or part of a test kit, a test system, a test protocol or laboratory test protocol, an instrument, a specimen receptacle, or software described in subparagraph (F), whether alone or in combination, including reagents, calibrators, and controls. (3) Notwithstanding subparagraph (2)(G), 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. ; (2) by adding at the end of paragraph (g) the following: (3) The term drug does not include an in vitro clinical test. ; and (3) in paragraph (h)(1), in the matter following clause (C), 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