TEST, (IVDP) SMOOTHMUSCLE ANTIBODY
Device Facts
| Record ID | K760156 |
|---|---|
| Device Name | TEST, (IVDP) SMOOTHMUSCLE ANTIBODY |
| Applicant | Zeus Scientific, Inc. |
| Product Code | DBE · Immunology |
| Decision Date | Jul 20, 1976 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5120 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) in serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own tissues).
