View all text of Subpart J [§ 864.9050 - § 864.9875]
§ 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.