21 C.F.R. § 864.9275

Current through September 30, 2024
Section 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 .

21 C.F.R. §864.9275

45 FR 60645, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000