StacksVerified U.S. regulatory reference

21 CFR §660.50

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Proper name and definition. The proper name of this product shall be Anti-Human Globulin which shall consist of one or more antiglobulin antibodies identified in § 660.55(a)(4).
  2. (b)Source. The source of this product shall be either serum from animals immunized with one or more human serum globulins or protein-rich fluids derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts.