TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323
Device Facts
| Record ID | K003064 |
|---|---|
| Device Name | TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 |
| Applicant | Roche Diagnostics Corp. |
| Product Code | DDG · Immunology |
| Decision Date | May 1, 2001 |
| 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.
