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e-CFR data is current as of July 9, 2020

Title 21Chapter ISubchapter HPart 864Subpart J → §864.9145


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products


§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]

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