ACE(TM) CEDIA(R) FERRITIN ASSAY
Device Facts
| Record ID | K950393 |
|---|---|
| Device Name | ACE(TM) CEDIA(R) FERRITIN ASSAY |
| Applicant | Schiapparelli Biosystems, Inc. |
| Product Code | JMG · Immunology |
| Decision Date | May 16, 1995 |
| 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.
