Title 21: Food and Drugs
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/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products / § 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).