§ 660.22Potency requirements with reference preparations.
(a)Potency requirements. Products for which reference Blood Grouping Reagents are available shall have a potency titer value at least equal to that of the reference preparation.
(b)Reference preparations. Reference Blood Grouping Reagents shall be obtained from the Center for Biologics Evaluation and Research (HFM-407) (see mailing addresses in § 600.2 of this chapter), and shall be used as described in the accompanying package insert for determining the potency of Blood Grouping Reagents.