| Device Type ID | 2997 |
| Device Name | System, Test, Systemic Lupus Erythematosus |
| Regulation Description | Systemic Lupus Erythematosus Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.5820 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DHC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |