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e-CFR data is current as of August 12, 2020

Title 21Chapter ISubchapter HPart 866Subpart F → §866.5680


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems


§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).

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