eCFR Reference Browser

---

title: "21 CFR §866.5775"

source: "https://www.ecfr.gov/current/title-21/section-866.5775"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "866"

part_subject: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"

subpart_code: "F"

subpart_subject: "Immunological Test Systems"

section_number: "866.5775"

section_subject: "Rheumatoid factor immunological test system."

cfr_reference: "21 CFR 866.5775"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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).

§866.5775 - Rheumatoid factor immuno­logical test system.

§866.5775 - Rheumatoid factor immunological test system.