COBAS CORE FREE T3 EIA
Device Facts
| Record ID | K942376 |
|---|---|
| Device Name | COBAS CORE FREE T3 EIA |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | CEC · Clinical Chemistry |
| Decision Date | Apr 21, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1695 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
