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Title 21 Part 866 → Subpart F → §866.5880

Title 21 → Chapter I → Subchapter H → Part 866 → Subpart F → §866.5880

Electronic Code of Federal Regulations e-CFR

Title 21 Part 866 → Subpart F → §866.5880

e-CFR data is current as of May 26, 2020

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5880


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems


§866.5880   Transferrin immunological test system.

(a) Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

(b) Classification. Class II (performance standards).