---
kind: "section"
citation: "21 C.F.R. § 866.5090"
title: "21"
number: "866.5090"
heading: "Antimitochondrial antibody immunological test system."
url: "https://uscodex.org/cfr/21/866.5090"
---

# §866.5090. Antimitochondrial antibody immunological test system.

- (a) **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).
- (b) **Classification.** Class II (performance standards).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.