; or (C) in the case of a test that was developed by the Centers for Disease Control and Prevention or another laboratory in a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention, by a clinical laboratory for which a certificate is in effect under section 353 of such Act that meets the requirements to perform tests of high complexity, and that is within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention; (4) the test does not have in effect an approval under section 515, a clearance under section 510(k), an authorization under section 513(f)(2), or an exemption under section 520(m), or licensure under section 351 of the Public Health Service Act; (5) any modification to the test on or after the date that is 45 days after the date of enactment of the VALID Act of 2023 is made by the initial developer, conforms with section 587C(a)(6)(A)(ii), and does not meet the criteria in subsection (d)(1); (6) when used as an investigational in vitro clinical test, such test complies with section 587S, as applicable; (7) the test is offered with an order from an authorized person as required under section 353 of the Public Health Service Act, and was offered with a prescription required under section 809.30(f) of title 21, Code of Federal Regulations prior to the effective date of this subchapter; (8) the test is not for use with home specimen collection, unless the specimen is collected with a collection container, receptacle, or kit that— (A) has been approved, cleared, or authorized by the Secretary for home specimen collection and the collection is performed pursuant to the approved, cleared, or authorized labeling, including any indication for use as prescription use or over-the-counter use, or (B) is exempt from premarket review and its use is consistent with applicable limitations on the exemption; (9) the test is not a specimen receptacle or instrument