; (B) an instrument under section 201(ss)(2)(D) or an in vitro clinical test that includes an instrument that is subject to section 587B, but is not approved under, or exempt from, section 587B; (C) a specimen receptacle under section 201(ss)(2)(E) or an in vitro clinical test that includes a specimen receptacle that is subject to section 587B, but is not approved under, or exempt from, section 587B; (D) an in vitro clinical test, including reagents used in such tests, intended for use for testing donors, donations, and recipients of blood, blood components, human cells, tissues, cellular-based products, or tissue-based products; (E) high-risk; (F) a combination product, unless such test has been determined to be eligible to be introduced into interstate commerce under a technology certification order pursuant to the regulatory pathway designation process described in section 587F, or as described in subsection (k), and the drug or biological product constituent part complies with the requirements of section 503(g) applicable to the drug or biological product; or (G) a first-of-a-kind in vitro clinical test, unless such test has been determined to be eligible to be introduced into interstate commerce under a technology certification order pursuant to the regulatory pathway designation process described in section 587F, or as described in subsection (k). (2) Eligible person The term eligible person means an in vitro clinical test developer unless such developer— (A) is a laboratory subject to section 353 of the Public Health Service Act and does not have in effect a certificate applicable to the category of laboratory examination or other procedure