1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
  6. Subpart B - Clinical Chemistry Test Systems
  7. 21 CFR § 862.1545
21 CFR § 862.1545
Parathyroid hormone test system
June 25, 2020
CFR

(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.

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§ 862.1542 Oxalate test system
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§ 862.1550 Urinary pH (nonquantitative) test system

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