21 C.F.R. § 866.5750 Radioallergosorbent (RAST) immunological test system.
Title 21 - Food and Drugs
(a) 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. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart F—Immunological Test Systems
§ 866.5750 Radioallergosorbent (RAST) immunological test system.