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 A—Antibody to Hepatitis B Surface Antigen (§660.1 to §660.6) > 660.3—Reference panel.

660.3—Reference panel.

A Reference Hepatitis B Surface Antigen Panel 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 for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen.

Code of Federal Regulations

[40 FR 29711, July 15, 1975, as amended at 49 FR 23834, June 8, 1984; 55 FR 11013, Mar. 26, 1990; 70 FR 14985, Mar. 24, 2005]