21 C.F.R. § 864.9285

Automated cell-washing centrifuge for immuno-hematology.

Last amended: 2016Year: 2026Length: 37 wordsSubsections: 1Official source

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]