Current through November 30, 2024
Section 660.20 - Blood Grouping Reagent(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