21 CFR 862.1695 — Radioimmunoassay, Free Thyroxine

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1695

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
CECRadioimmunoassay, Free Thyroxine2923rd Party
Innolitics

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