Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 7 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER F - BIOLOGICS
/ PART 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
/ Subpart A - Antibody to Hepatitis B Surface Antigen / § 660.5 Specificity.
§ 660.5 Specificity.
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.