DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
Device Facts
| Record ID | K921183 |
|---|---|
| Device Name | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT |
| Applicant | Shield Diagnostics, Ltd. |
| Product Code | DBM · Immunology |
| Decision Date | Jun 19, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5090 |
| Device Class | Class 2 |
Regulatory Classification
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).
