REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)
Device Facts
| Record ID | K001603 |
|---|---|
| Device Name | REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) |
| Applicant | Repromedix Corp. |
| Product Code | KLI · Clinical Chemistry |
| Decision Date | Oct 5, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1700 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
