U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
Searching within:
All TitlesTitle 21Chapter IPart 864Subpart J - Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
Exit search mode at current location
Exit search mode at current location
(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).
