NRX · Complement 4d (C4d) And Complement Receptor 1 (Cr1)
Immunology · 21 CFR 866.5820 · Class 2
Overview
| Product Code | NRX |
|---|---|
| Device Name | Complement 4d (C4d) And Complement Receptor 1 (Cr1) |
| Regulation | 21 CFR 866.5820 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
