21 CFR 866.5340 — Ferritin, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5340
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control | 2 | 87 | 3rd Party |
| JMG | Radioimmunoassay (Two-Site Solid Phase), Ferritin | 2 | 24 | 3rd Party |
