QUANTIMUNE T-3 FIA
Device Facts
| Record ID | K790960 |
|---|---|
| Device Name | QUANTIMUNE T-3 FIA |
| Applicant | Bio-Rad |
| Product Code | CDP · Clinical Chemistry |
| Decision Date | Aug 10, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1710 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.