Each filling of the product shall be specific for antibody to hepatitis B surface antigen, as determined by specificity tests found acceptable by the Director, Center for Biologics Evaluation and Research.
21 CFR Part 660 · Additional Standards for Diagnostic Substances for Laboratory Tests
§ 660.5 Specificity
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 29712 15 Jul 1975
- 49 FR 23834 8 Jun 1984
- 55 FR 11013 26 Mar 1990