ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY
Device Facts
| Record ID | K001127 |
|---|---|
| Device Name | ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY |
| Applicant | The Binding Site, Ltd. |
| Product Code | MOB · Immunology |
| Decision Date | Aug 30, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5660 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).
