21 C.F.R. § 660.22 Potency requirements with reference preparations.
Title 21 - Food and Drugs
(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. [53 FR 12764, Apr. 19, 1988, as amended at 67 FR 9587, Mar. 4, 2002; 70 FR 14985, Mar. 24, 2005]
Title 21: Food and Drugs
PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
Subpart C—Blood Grouping Reagent
§ 660.22 Potency requirements with reference preparations.
