866.5350—Fibrinopeptide A immuno-logical test system.
(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).