§ 866.5775. Rheumatoid factor immunological test system.
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/us/cfr/t21/s§ 866.5775·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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).