A Reference Hepatitis B Surface Antigen Panel shall be obtained from the Food and Drug Administration, Center for Biologics Evaluation and Research, Reagents and Standards Shipping, 10903 New Hampshire Ave., Bldg. 75, Rm. G704, Silver Spring, MD 20993-0002 and shall be used for determining the potency and specificity of Antibody to Hepatitis B Surface Antigen.
21 CFR Part 660 · Additional Standards for Diagnostic Substances for Laboratory Tests
§ 660.3 Reference panel
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Amendment history
Federal Register documents that created or amended this section.
- 40 FR 29711 15 Jul 1975
- 49 FR 23834 8 Jun 1984
- 55 FR 11013 26 Mar 1990
- 70 FR 14985 24 Mar 2005
- 80 FR 18093 3 Apr 2015