21 CFR 864.9175 — System, Test, Automated Blood Grouping And Antibody

Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9175

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
KSZSystem, Test, Automated Blood Grouping And Antibody24
OQXSelf-Contained Blood Grouping 20
PBCManual Blood Grouping And Antibody Test Systems20
Innolitics

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