HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0
Device Facts
| Record ID | K932373 |
|---|---|
| Device Name | HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 |
| Applicant | Hemagen Diagnostics, Inc. |
| Product Code | MID · Immunology |
| Decision Date | Jul 16, 1993 |
| 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).
