21 CFR § 864.9175
Automated blood grouping and antibody test system
June 25, 2020
(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]