21 CFR § 660.20
Blood Grouping Reagent
June 25, 2020
(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.
[53 FR 12764, Apr. 19, 1988, as amended at 65 FR 77499, Dec. 12, 2000; 81 FR 38925, June 15, 2016]
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