Code of Federal Regulations · Section

§ 864.9175 — Automated Blood Grouping And Antibody Test System

21 C.F.R. § 864.9175

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(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).

Authorizing Statute