ANTI-HUMAN SERUM
Device Facts
| Record ID | K791282 |
|---|---|
| Device Name | ANTI-HUMAN SERUM |
| Applicant | Diagnostica, Inc. |
| Product Code | DGQ · Immunology |
| Decision Date | Oct 17, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5700 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.
