21 CFR 660.20
§ 660.20 Blood Grouping Reagent.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 660.20, § 660.20 Blood Grouping Reagent, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88545
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Full text
(a) Proper name and definition. The proper name of this product shall be Blood Grouping Reagent and it shall consist of an antibody-containing fluid containing one or more of the blood grouping antibodies listed in § 660.28(a)(4).
(b) Source. The source of this product shall be blood, plasma, serum, or protein-rich fluids, such as those derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.