§ 866.5350. Fibrinopeptide A immunological test system.
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/us/cfr/t21/s§ 866.5350·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A fibrinopeptide A immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the fibrinopeptide A (a blood-clotting factor) in plasma and other body fluids. Measurement of fibrinopeptide A may aid in the diagnosis and treatment of certain blood-clotting disorders.
(b)Classification. Class II (performance standards).