21 CFR § 864.9145 - Processing system for frozen blood.

---
identifier: "/us/cfr/t21/s864.9145"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.9145 - Processing system for frozen blood."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.9145"
section_name: "Processing system for frozen blood."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 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]