Regulations last checked for updates: Feb 13, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 864.9145 - Processing system for frozen blood.

(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]
authority: 21 U.S.C. 351,360,360c,360e,360j,360
cite as: 21 CFR 864.9145