21 CFR 866.5500 — System, Test, Hypersensitivity Pneumonitis

Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5500

Identification

A hypersensitivity pneumonitis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulin antibodies in serum which react specifically with organic dust derived from fungal or animal protein sources. When these antibodies react with such dusts in the lung, immune complexes precipitate and trigger an inflammatory reaction (hypersensitivity pneumonitis). Measurement of these immunoglobulin G antibodies aids in the diagnosis of hypersensitivity pneumonitis and other allergic respiratory disorders.

Classification Rationale

Class II (performance standards).

Product Codes