21 C.F.R. § 864.9285
Automated cell-washing centrifuge for immuno-hematology.
Cite as 21 C.F.R. § 864.9285 (2026)
(a) Identification. An automated cell-washing centrifuge for immuno-hematology is a device used to separate and prepare cells and sera for further in vitro diagnostic testing. (b) Classification. Class II (performance standards). [45 FR 60646, Sept. 12, 1980]