; (B) an exemption from premarket approval under section 587C or 587G; or (C) investigational use pursuant to section 587S. (9) If it is not in conformity with any condition established under section 587B or 587D. (10) If it purports to be an in vitro clinical test subject to an exemption under section 587C and it fails to meet or maintain any criteria, condition, or requirement of such exemption. (11) If it has been granted an exemption under section 587S for investigational use, and the person granted such exemption or any investigator who uses such in vitro clinical test under such exemption fails to comply with a requirement prescribed by or under such section. (12) If it fails to meet the quality requirements prescribed in or established under section 587K (as applicable), or the methods used in, or facilities or controls used for, its development, packaging, storage, or installation are not in conformity with applicable requirements established under such section. (13) If it has been developed, processed, packaged, or held in any establishment, factory, or warehouse and the owner, operator or agent of such establishment, factory, or warehouse delays, denies, or limits an inspection, or refuses to permit entry or inspection. (14) If it is not in compliance with any restriction required under section 587O. 587W. Misbranding An in vitro clinical test shall be deemed to be misbranded: (1) If its labeling is false or misleading in any particular. (2) If in a package form unless it bears a label containing— (A) the name and place of business of the test developer, packager, or distributor