Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products / § 864.9275 Blood bank centrifuge for in vitro diagnostic use.
§ 864.9275 Blood bank centrifuge for in vitro diagnostic use.
(a) Identification. A blood bank centrifuge for in vitro diagnostic use is a device used only to separate blood cells for further diagnostic testing.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.