NEIA TRANSFERRIN ENZYMEIMMUNOASSAY
Device Facts
| Record ID | K813288 |
|---|---|
| Device Name | NEIA TRANSFERRIN ENZYMEIMMUNOASSAY |
| Applicant | New England Immunology Assoc. |
| Product Code | DDG · Immunology |
| Decision Date | Dec 17, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5880 |
| Device Class | Class 2 |
Regulatory Classification
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.
