; and (ii) performed in the same laboratory in which it was developed or by another such laboratory certified by the Secretary under section 353 of the Public Health Service Act that meets the requirements for performing high complexity testing and is under common ownership with the laboratory that designed and manufactured the test. (2) Test instrument labeling 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 of the Code of Federal Regulations, as it appears on the date of enactment of this subchapter and amended thereafter. (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 system. (4) Lab Research or Investigational Use A shipment or other delivery of an in vitro clinical test for research or investigational use pursuant to section 587A(m) 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 (b) and subsection (c)(1). (6) Analyte Specific Reagents The labeling for analyte specific reagents shall bear the following statement: This product is intended solely for further development of an in vitro clinical test and is exempt from most FDA regulation. This product must be evaluated by the in vitro clinical test developer in accordance with applicable requirements. . If the labeling of an analyte specific reagent bears the information set forth