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
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Adulterated drugs and devices21 U.S.C. § 351