{"data":{"id":"us/21-cfr-660.54","jurisdiction":"us","citation":"21 CFR 660.54","heading":"Potency tests, specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.","body":"The following tests shall be performed using test procedures approved by the Director, Center for Biologics Evaluation and Research:\n(a) Potency tests for determining anti-IgG and anti-complement activity.\n(b) Specificity tests, tests for heterospecific antibodies, and additional tests for nonspecific properties.","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 F—Anti-Human Globulin"],"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":"0a4c530af666e2d490328c2cd5768b1f3f31eb3414e216546c6a52055867810a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-660.53","next":"us/21-cfr-660.55"},"notice":"GroundRules: Original legal text. Not legal advice."}