NRI · Autoantibodies, Nuclear Pore Glycoprotein Gp210
Immunology · 21 CFR 866.5090 · Class 2
Overview
| Product Code | NRI |
|---|---|
| Device Name | Autoantibodies, Nuclear Pore Glycoprotein Gp210 |
| Regulation | 21 CFR 866.5090 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K061842 | QUANTA LITE PBC SCREEN IGG/IGA ELISA | Inova Diagnostics, Inc. | Oct 18, 2006 | SESE |
| K040885 | QUANTA LITE GP210 ELISA | Inova Diagnostics, Inc. | Jun 25, 2004 | SESE |
Top Applicants
- Inova Diagnostics, Inc. — 2 clearances
