21 C.F.R. § 866.5110

Antiparietal antibody immunological test system.

Last amended: 2016Year: 2026Length: 102 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 866.5110 (2026)

(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 12 to be absorbed by the body. The measurements aid in the diagnosis of vitamin B 12 deficiency (or pernicious anemia), atrophic gastritis (inflammation of the stomach), and autoimmune connective tissue diseases (diseases resulting when the body produces antibodies against its own tissues). (b) Classification. Class II (performance standards).