21 C.F.R. § 864.9145

Processing system for frozen blood.

Last amended: 2016Year: 2026Length: 66 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 864.9145 (2026)

(a) Identification. A processing system for frozen blood is a device used to glycerolize red blood cells prior to freezing to minimize hemolysis (disruption of the red cell membrane accompanied by the release of hemoglobin) due to freezing and thawing of red blood cells and to deglycerolize and wash thawed cells for subsequent reinfusion. (b) Classification. Class II (performance standards). [45 FR 60639, Sept. 12, 1980]