21 C.F.R. § 864.9175
Automated blood grouping and antibody test system.
Cite as 21 C.F.R. § 864.9175 (2026)
(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. (b) Classification. Class II (performance standards). [45 FR 60641, Sept. 12, 1980]