21 CFR 862.1700 — Radioimmunoassay, Total Thyroxine
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1700
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | 2 | 121 | |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 | 86 |
Special Controls
CDX — Radioimmunoassay, Total Thyroxine
*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.
eCFR
KLI — Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
*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.
eCFR
