FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT
Device Facts
| Record ID | K884201 |
|---|---|
| Device Name | FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT |
| Applicant | Cyberfluor, Inc. |
| Product Code | CEE · Clinical Chemistry |
| Decision Date | Dec 14, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1685 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A thyroxine-binding globulin test system is a device intended to measure thyroxine (thyroid)-binding globulin (TBG), a plasma protein which binds thyroxine, 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.
