ACCESS R-CLONE ANA PROFILE ASSAY
Device Facts
| Record ID | K885048 |
|---|---|
| Device Name | ACCESS R-CLONE ANA PROFILE ASSAY |
| Applicant | Lipogen, Inc. |
| Product Code | DHC · Immunology |
| Decision Date | Jan 24, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5820 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).
