StacksVerified U.S. regulatory reference

21 CFR §660.20

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 Blood Grouping Reagent and it shall consist of an antibody-containing fluid containing one or more of the blood grouping antibodies listed in § 660.28(a)(4).
  2. (b)Source. The source of this product shall be blood, plasma, serum, or protein-rich fluids, such as those derived from stable immunoglobulin-secreting cell lines maintained either in tissue cultures or in secondary hosts.