21 CFR § 864.9175 Hematology and Pathology Devices

§ 864.9175 Automated blood grouping and antibody test system.

Current through Sep 8, 2026 · Read all of Part 864

(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]

← § 864.9165 Blood establishment computer software and accessories.§ 864.9185 Blood grouping view box. →