; (D) the test kit or test protocol is not intended for use— (i) in settings for which a certificate of waiver is in effect under section 353 of the Public Health Service Act; (ii) without a prescription; (iii) at home; or (iv) in testing donors, donations, and recipients of blood, blood components, human cells, tissues, cellular-based products, or tissue-based products; (E) the test developer makes the documentation described under subparagraph (C) available to the Secretary upon request