21 CFR 866.5880 — Transferrin, Rhodamine, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5880
Identification
A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DDD | Transferrin, Rhodamine, Antigen, Antiserum, Control | 2 | 1 | 3rd Party |
| DDG | Transferrin, Antigen, Antiserum, Control | 2 | 48 | 3rd Party |
| DDI | Transferrin, Fitc, Antigen, Antiserum, Control | 2 | 2 | 3rd Party |
| JNM | Immunochemical, Transferrin | 2 | 3 | 3rd Party |
