21 CFR § 864.9650 - Quality control kit for blood banking reagents.

---
identifier: "/us/cfr/t21/s864.9650"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.9650 - Quality control kit for blood banking reagents."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.9650"
section_name: "Quality control kit for blood banking reagents."
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"
---


# 864.9650 Quality control kit for blood banking reagents.

(a) *Identification.* A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.

(b) *Classification.* Class II (performance standards).

[45 FR 60649, Sept. 12, 1980]