21 CFR 866.5090 — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5090
Identification
An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 27 | 3rd Party |
| NRI | Autoantibodies, Nuclear Pore Glycoprotein Gp210 | 2 | 2 | 3rd Party |
| NUM | Autoantibodies, Nuclear Body Protein, Sp100 | 2 | 1 | 3rd Party |
