21 CFR 864.9050
§ 864.9050 Blood bank supplies.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.9050, § 864.9050 Blood bank supplies, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89406
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Full text
(a) Identification. Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
(b) Classification. Class I (general controls).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.