21 CFR 864.9650
§ 864.9650 Quality control kit for blood banking reagents.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.9650, § 864.9650 Quality control kit for blood banking reagents, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89427
- Permanent ID
ys:prov:89427@1- SHA-256
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.