21 CFR 862.1710 — Radioimmunoassay, Total Triiodothyronine

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1710

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.

Classification Rationale

Class II. This 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 CodeDevice NameClassDevicesAttributes
CDPRadioimmunoassay, Total Triiodothyronine2144
Innolitics

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