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Title 21 → Chapter I → Subchapter H → Part 862 → Subpart B → §862.1145 |
Title 21: Food and Drugs
PART 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart B—Clinical Chemistry Test Systems
§862.1145 Calcium test system.
(a) Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
(b) Classification. Class II.