Radioallergosorbent (RAST) immunological test system.

§866.5750
Radioallergosorbent (RAST) immunological test system.
Identification. A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.
Classification. Class II (performance standards).