NJF · Antibodies, Anti-Actin, Anti-Smooth Muscle
Immunology · 21 CFR 866.5120 · Class 2
Overview
| Product Code | NJF |
|---|---|
| Device Name | Antibodies, Anti-Actin, Anti-Smooth Muscle |
| Regulation | 21 CFR 866.5120 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K021648 | QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA | Inova Diagnostics, Inc. | Sep 20, 2002 | SESE |
Top Applicants
- Inova Diagnostics, Inc. — 1 clearance
