; and (bb) is under common ownership and control as the laboratory that developed the test. (2) Test instrument labeling Unless the instrument is the entire test system, the labeling for an instrument is not required to bear the information indicated in paragraphs (3), (4), (5), (7), (8), (9), (10), (11), (12), and (13) of section 809.10(b) of title 21, Code of Federal Regulations (or any successor regulations). (3) Reagent labeling For purposes of compliance with subsection (c)(1), the labeling for a reagent intended for use as a replacement in an in vitro clinical test may be limited to that information necessary to identify the reagent adequately and to describe its proper use in the test. (4) Investigational use A shipment or other delivery of an in vitro clinical test for investigational use pursuant to section 587S shall be exempt from the labeling requirements of subsections (b) and (c)(1) and from any standard promulgated through regulations, except as required under section 353 of the Public Health Service Act or section 587R of this Act. (5) General purpose laboratory reagents The labeling of general purpose laboratory reagents (such as hydrochloric acid) whose uses are generally known by persons trained in their use need not bear the directions for use required by subsection (c)(1)(A). (6) Over-the-counter test specimen receptacle labeling The labeling for over-the-counter test specimen receptacles for drugs of abuse testing shall bear the name and place of business of the developer included in the registration under section 587J and any information specified in applicable regulations promulgated under this section, in language appropriate for the intended users. (e) Tests in the strategic national stockpile (1) In general The Secretary may grant an exception or alternative to any provision listed in this section, unless explicitly required by a statutory provision outside this subchapter, for specified lots, batches, or other units of an in vitro clinical test, if the Secretary determines that