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Electronic Code of Federal Regulations

e-CFR data is current as of September 19, 2019

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5775


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


§866.5775   Rheumatoid factor immunological test system.

(a) Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

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

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