{"data":{"id":"us/21-cfr-660.1","jurisdiction":"us","citation":"21 CFR 660.1","heading":"Antibody to Hepatitis B Surface Antigen.","body":"(a) Proper name and definition. The proper name of this product shall be Antibody to Hepatitis B Surface Antigen. The product is defined as a preparation of serum containing antibody to hepatitis B surface antigen.\n(b) Source. The source of this product shall be plasma or blood, obtained aseptically from animals immunized with hepatitis B surface antigen, which have met the applicable requirements of § 600.11 of this chapter, or from human donor whose blood is positive for hepatitis B surface antigen.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"377fa3093ecbb27a5335888feff17a4c190fd97cf4159bf22f758b15bfefdd12","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-640.130","next":"us/21-cfr-660.2"},"notice":"GroundRules: Original legal text. Not legal advice."}