CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER F—BIOLOGICS (parts 600 to 680) > PART 660—ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS > SUBPART F—Anti-Human Globulin (§660.50 to §660.55) > 660.52—Reference preparations.

660.52—Reference preparations.

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.

Code of Federal Regulations

[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]