21 CFR § 866.5680 - Myoglobin immunological test system.

---
identifier: "/us/cfr/t21/s866.5680"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 866.5680 - Myoglobin immunological test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "866.5680"
section_name: "Myoglobin immunological test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "866"
part_name: "IMMUNOLOGY AND MICROBIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "47 FR 50823, Nov. 9, 1982, unless otherwise noted."
cfr_part: "866"
---


# 866.5680 Myoglobin immunological test system.

(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).