21 C.F.R. § 866.5350

Current through September 30, 2024
Section 866.5350 - Fibrinopeptide A immunological 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).

21 C.F.R. §866.5350