DDI · Transferrin, Fitc, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5880 · Class 2
Overview
| Product Code | DDI |
|---|---|
| Device Name | Transferrin, Fitc, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5880 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K842071 | FIAX TRANSFERRIN TEST KIT | Intl. Diagnostic Technology | Jul 11, 1984 | SESE |
| K772074 | RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN | Gelman Instrument Co. | Feb 3, 1978 | SESE |
Top Applicants
- Intl. Diagnostic Technology — 1 clearance
- Gelman Instrument Co. — 1 clearance
