Each filling of the product shall be specific for Hepatitis B Surface Antigen as determined by specificity tests found acceptable to the Director, Center for Biologics Evaluation and Research.
21 CFR Part 660 · Additional Standards for Diagnostic Substances for Laboratory Tests
§ 660.44 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.
- 44 FR 36382 22 Jun 1979
- 49 FR 23834 8 Jun 1984
- 55 FR 11013 26 Mar 1990