StacksVerified U.S. regulatory reference

21 CFR §864.9175

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.
  2. (b)Classification. Class II (performance standards).