eCFR Reference Browser

---

title: "21 CFR §866.5680"

source: "https://www.ecfr.gov/current/title-21/section-866.5680"

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: "866.5680"

section_subject: "Myoglobin immunological test system."

cfr_reference: "21 CFR 866.5680"

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 myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

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

§866.5680 - Myoglobin immunological test system.