21 CFR § 862.1545 - Parathyroid hormone test system.

---
identifier: "/us/cfr/t21/s862.1545"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 862.1545 - Parathyroid hormone test system."
title_number: 21
title_name: "Food and Drugs"
section_number: "862.1545"
section_name: "Parathyroid hormone test system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "862"
part_name: "CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 16122, May 1, 1987, unless otherwise noted."
cfr_part: "862"
---


# 862.1545 Parathyroid hormone test system.

(a) *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.

(b) *Classification.* Class II.