eCFR Reference Browser

---

title: "21 CFR §866.5270"

source: "https://www.ecfr.gov/current/title-21/section-866.5270"

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: "866.5270"

section_subject: "C-reactive protein immunological test system."

cfr_reference: "21 CFR 866.5270"

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 C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

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

§866.5270 - C-reactive protein immuno­logical test system.

§866.5270 - C-reactive protein immunological test system.