TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

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).