21 C.F.R. § 660.52 Reference preparations.
Title 21 - Food and Drugs
Reference Anti-Human Globulin preparations 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 Anti-Human Globulin. [50 FR 5579, Feb. 11, 1985, as amended at 50 FR 16474, Apr. 26, 1985; 51 FR 15611, Apr. 25, 1986; 55 FR 11015, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 70 FR 14986, Mar. 24, 2005]
Title 21: Food and Drugs
PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
Subpart F—Anti-Human Globulin
§ 660.52 Reference preparations.
