; (C) has been found to have submitted information that— (i) makes false or misleading statements about a technology certification order previously issued or an application approved under section 587B; or (ii) violates any requirement of this subchapter related to technology certification under this section or approval under section 587B, where such violation exposes persons to serious risk of illness, injury, or death. (2) Eligible in vitro clinical test An in vitro clinical test is eligible under subsection (a)(2) for exemption from premarket review under section 587B unless— (A) such test is— (i) a component or part of an in vitro clinical test as described under section 201(ss)(1)(B)(v); (ii) an instrument under section 201(ss)(1)(B)(ii); (iii) a specimen receptacle under section 201(ss)(1)(B)(iii); or (iv) 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; or (B) unless otherwise permitted pursuant to section 587F, such test is— (i) a first-of-a-kind in vitro clinical test; (ii) a test system for home use; (iii) a high-risk in vitro clinical test; (iv) a cross-referenced in vitro clinical test