21 C.F.R. § 866.5350
Fibrinopeptide A immunological test system.
Cite as 21 C.F.R. § 866.5350 (2026)
(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).