View all text of Subpart F [§ 866.5040 - § 866.5960]
§ 866.5110 - Antiparietal antibody immunological test system.
(a) Identification. An antiparietal antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific antibody for gastric parietal cells in serum and other body fluids. Gastric parietal cells are those cells located in the stomach that produce a protein that enables vitamin B
(b) Classification. Class II (performance standards).