; (ii) is developed and used in a laboratory certified to perform high-complexity testing pursuant to section 353 of the Public Health Service Act ( 42 U.S.C. 263a ) and such laboratory— (I) is operating under an authorization of the State (as defined in section 2 of the Public Health Service Act ( 42 U.S.C. 201 )) in which such laboratory is located and such State has notified the Secretary of its intention to review tests intended to diagnose SARS–CoV–2 or diagnose the virus that causes COVID–19 to be used in such State; (II) has notified the Secretary of such use for such purpose in such State; and (III) includes a statement together with the results of the test that reads: This test was developed for use as a part of a response to the public health emergency declared to address the outbreak of COVID–19. This test has not been reviewed by the Food and Drug Administration ; or (iii) is developed by a commercial test manufacturer that, with respect to such test— (I) validates such test prior to use to detect SARS–CoV–2 or diagnose the virus that causes COVID–19, including by obtaining confirmation of validation using an assay authorized under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ); (II) notifies the Secretary of such use; and (III) includes a statement together with the results of the test that reads: This test has not been FDA cleared or approved. This test has been authorized by FDA under an emergency use authorization for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens . (C) Such term shall not include a test described in clause (i) or (iii) of subparagraph (B) if— (i) the emergency use authorization request submitted by a laboratory or manufacturer described in such respective clause with respect to such test has been denied