GroundRules
21 CFR 864.9175: Automated blood grouping and antibody test system.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
(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).
Collected 2026-08-27T02:24:47Z. Source file · JSON