21 CFR 866.5680 — Myoglobin, Rhodamine, Antigen, Antiserum, Control

Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5680

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DDOMyoglobin, Rhodamine, Antigen, Antiserum, Control203rd Party
DDRMyoglobin, Antigen, Antiserum, Control2463rd Party
DEAMyoglobin, Fitc, Antigen, Antiserum, Control203rd Party
MVEBiosensor, Immunoassay, Myoglobin213rd Party
Innolitics

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