21 CFR 866.5110 — Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5110
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 B12 to be absorbed by the body. The measurements aid in the diagnosis of vitamin B12 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).
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DBJ | Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 | 3rd Party |
| MLE | Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control | 2 | 3 | 3rd Party |
