; or (B) is developed, manufactured, and used solely within a single laboratory certified by the Secretary under section 353 of the Public Health Service Act that meets the requirements for performing high-complexity testing. (2) Regulations The label of an in vitro clinical test shall state the name and place of business of its developer and meet the requirements set forth in regulations promulgated under this section. (c) Labeling (1) In general Labeling accompanying an in vitro clinical test, including labeling in the form of a package insert, standalone laboratory reference document, or other similar document except the labeling specified in paragraph (2), shall include adequate directions for use and shall meet the requirements set forth in regulations promulgated under this section, except as provided in subsection (d) or (e). Labeling in the form of a package insert shall also include the information in subparagraph (A) or (B) of paragraph (2). (2) Content (A) In general Labeling accompanying an in vitro clinical test that is in the form of a test report template or ordering information shall include— (i) the test listing number that was provided to the developer at the time of listing; (ii) instructions for how and where to report an adverse event under section 587L; (iii) instructions for how and where to access the performance summary data displayed in the listing database for the test; (iv) the intended use of the in vitro clinical test; and (v) any warnings, contraindications, or limitations. (B) Public availability of information The Secretary shall make all of the information described in subparagraph (A) with respect to each in vitro clinical test available to the public, as applicable, in accordance with section 587T, except to the extent that the Secretary determines that such information is— (i) trade secret or commercial confidential information