21 CFR 866.5350 — Fibrinopeptide A, Antigen, Antiserum, Control

Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5350

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
DANFibrinopeptide A, Antigen, Antiserum, Control233rd Party
Innolitics

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