Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter F - Biologics |
Part 660 - Additional Standards for Diagnostic Substances for Laboratory Tests |
Subpart A - Antibody to Hepatitis B Surface Antigen |
§ 660.1 - Antibody to Hepatitis B Surface Antigen. |
§ 660.2 - General requirements. |
§ 660.3 - Reference panel. |
§ 660.4 - Potency test. |
§ 660.5 - Specificity. |
§ 660.6 - Samples; protocols; official release. |