21 CFR § 864.9175 - Automated blood grouping and antibody test system.

§ 864.9175 Automated blood grouping and antibody test system.

(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]