21 CFR 862.1545 — Radioimmunoassay, Parathyroid Hormone

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1545

Identification

A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
CEWRadioimmunoassay, Parathyroid Hormone2863rd Party
Innolitics

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