Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter H - MEDICAL DEVICESPart 864 - HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J - PRODUCTS USED IN ESTABLISHMENTS THAT MANUFACTURE BLOOD AND BLOOD PRODUCTS
Section 864.9175 - Automated blood grouping and antibody test system

21 C.F.R. § 864.9175

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Section 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).

21 C.F.R. §864.9175

45 FR 60641, Sept. 12, 1980