VARELISA M2 ANTIBODIES
Device Facts
| Record ID | K945607 |
|---|---|
| Device Name | VARELISA M2 ANTIBODIES |
| Applicant | Elias U.S.A., Inc. |
| Product Code | DBM · Immunology |
| Decision Date | Jan 24, 1995 |
| 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).
