{"data":{"id":"us/21-cfr-660.40","jurisdiction":"us","citation":"21 CFR 660.40","heading":"Hepatitis B Surface Antigen.","body":"(a) Proper name and definition. The proper name of this product shall be Hepatitis B Surface Antigen (HBsAg), which shall consist of a serum or tissue preparation containing one or more subtypes of the Hepatitis B Surface Antigen.\n(b) Source. The source of the product shall be blood, plasma, serum, or tissue, obtained aseptically from nonhuman primates that have met the applicable requirements of § 600.11 of this chapter, or from human donors whose blood is positive for the 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 E—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":"25a5516c8423e695d3f963ed02df6093e51afa84bba1900cb1637c02921e01bb","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-660.36","next":"us/21-cfr-660.41"},"notice":"GroundRules: Original legal text. Not legal advice."}