DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
Device Facts
| Record ID | K935528 |
|---|---|
| Device Name | DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH |
| Applicant | E.I. Dupont DE Nemours & Co., Inc. |
| Product Code | DBF · Immunology |
| Decision Date | Jan 28, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.
